Brand Name: cobas c 6000 MODULAR Series System e 601 cobas c 8000 MODULAR Series System - e 602 Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 03022109001 03023109973 03739040001 03739040692 05023572001 05023599001 cobas e 601 module 04745922001 04745922692 05036348001 05036348692 05860652001 cobas e 602 module 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.
This recall has been terminated (originally issued January 16, 2018).
- Company
- Roche Diagnostics Corporation
- Recall Initiated
- June 29, 2017
- Posted
- January 16, 2018
- Terminated
- January 24, 2020
- Recall Number
- Z-0378-2018
- Quantity
- 2517
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Roche has confirmed that a possible sample mismatch issue may occur on the MODULAR ANALYTICS E 170 module, cobas e 601 analyzer, or cobas e 602 analyzer due to a software limitation.
Distribution
USA (nationwide) Distribution
Lot / Code Info
Serial Number 2072-26 27P6-20 15S2-20 2717-18 2719-02 1544-11 1686-03 1534-12 1698-04 1549-04 2275-12 2263-16 2263-17 2497-16 1849-01 1570-15 26F0-17 2256-18 2564-30 2850-05 2384-12 2384-18 2399-08 2230-19 2230-20 2379-14 2381-02 27Z8-01 2058-22 1909-13 1909-01 27V5-20 15U5-18 2308-01 2087-07 1984-05 1985-07 26D3-30 2497-01 1861-18 1861-19 26D0-27 26D1-21 1480-14 1480-15 1488-01 1488-02 26C3-12 26F0-19 26F0-27 26D9-24 2107-35 2348-12 2348-13 1423-16 2237-18 2240-09 2240-10 16J8-05 16J8-06 16L7-20 16K2-17 16K2-18 16K2-19 16K2-20 16K3-01 16K3-06 16K3-07 16K3-08 16K3-09 16L4-03 16L4-04 26D1-25 26D1-26 26D1-28 26D1-29 2328-03 2437-13 2072-29 2072-30 2064-12 1931-11 2080-35 1936-08 2049-15 27Z0-09 27Z0-10 1911-11 2581-18 2062-14 2074-05 1430-16 1430-17 1691-17 1691-18 1985-13 1989-19 1739-19 2578-25 13B8-12 1169-06 1169-08 1169-09 1211-16 1211-17 1211-18 1224-10 1458-04 2543-10 27J6-15 2048-05 2406-27 26B3-30 1927-19 1914-13 1914-11 27J7-06 2822-07 2822-08 2535-23 2306-04 1159-19 2867-11 2711-02 27Y6-19 2107-20 2195-34 2106-20 2079-34 27M5-13 15D1-02 15C9-10 15F0-17 15F0-18 2137-15 1872-01 2195-40 2102-30 2428-02 2539-08 1377-14 2495-01 1490-16 15C5-16 15C5-17 15C5-20 15C6-01 2250-02 26H6-29 2423-15 2539-06 1377-12 2307-26 2307-27 2227-11 2080-24 1128-05 1128-06 14B1-02 14B2-13 2467-05 27Z8-09 26E4-05 2413-14 2423-19 2086-27 27Z0-14 27Z0-16 2145-16 2321-26 2321-25 26F1-20 26F1-19 1305-40 26G7-23 26G8-09 27L8-12 27X4-14 2719-07 27S8-20 15U1-20 26A4-28 26D1-22 2368-06 1128-19 2427-29 2539-07 1377-13 1357-08 1357-09 1357-10 1344-05 1344-06 14B1-01 1344-02 1344-03 1344-04 1469-03 1469-04 1469-05 1476-20 1482-11 1483-01 1483-17 1483-18 1483-19 1483-20 1484-16 1484-17 1484-18 1490-18 1490-19 1490-20 14A3-01 14A3-02 14A3-03 15B7-01 15B7-02 2430-27 2430-29 15B7-03 2327-25 2347-04 2369-04 2332-04 2332-09 27S4-02 27S4-03 2230-14 2230-18 1211-15 1211-14 15D2-04 15D2-05 15D3-12 15F0-15 15F0-16 16P4-02 16P4-03 2061-21 14A9-16 14A9-17 14A9-18 15B7-04 2256-19 2865-20 2867-01 2070-11 2070-13 2720-17 16X4-17 2102-29 2192-37 2196-02 2535-18 2842-03 2896-04 16P4-04 16P4-07 16P4-08 16P4-09 2311-12 2311-13 1871-09 1125-07 1128-02 2059-28 15H8-11 15H8-12 1996-01 2396-04 2399-06 2068-24 2283-14 2080-02 2577-04 2047-10 2107-05 26E4-10 27J7-04 2585-07 2581-08 2581-13 2327-11 2396-07 2413-01 2413-04 185731 1867-06 2037-07 2423-14 1549-02 27Z8-02 1860-19 2074-25 2087-09 2103-35 1924-15 2192-02 2437-19 2437-20 27Z0-03 2437-17 1913-03 1913-04 2488-05 2402-05 26C3-11 26C9-12 26E4-08 26F3-21 1545-05 1844-14 2822-09 2822-10 1303-31 1303-32 1357-19 1357-20 2402-30 2195-38 2196-01 2080-11 2080-17 2226-17 2439-12 2107-02 1988-03 2086-40 2195-24 2195-06 2195-08 2072-39 2041-12 2047-07 2192-15 2192-08 1736-04 1991-08 1871-06 2037-14 2055-30 2055-35 2873-02 2891-13 1990-05 192506 2894-12 1936-14 1928-19 2848-17 2867-08 2058-21 2058-25 2073-01 2111-04 130833 130834 2850-06 1334-12 1334-13 1334-14 1476-01 1476-02 1476-12 2049-29 2049-30 28E5-14 2347-11 2367-09 27Z8-12 2842-02 192418 1936-09 28A2-10 28AO-16 2208-17 2227-10 15J5-02 15J5-03 1852-15 2256-15 1461-03 1461-04 1476-11 16M7-01 16M7-16 14B3-06 14B3-07 16K3-15 16K3-16 16K3-17 16K3-18 16K3-19 16K3-20 16K4-07 16K4-11 16K4-20 16K5-01 16K5-02 16K5-03 16K5-04 16K5-05 16K5-09 16K5-10 16K7-04 16K7-05 16K7-06 16L4-05 16L4-06 16L4-07 16L4-08 16L7-19 16L5-03 16L7-17 16P1-13 16P1-14 16P1-15 16P2-19 1417-20 2581-25 2587-14 1431-14 2065-12 1545-03 16M7-13 16M8-01 16M8-02 16P1-11 2275-13 2267-19 2275-09 2275-10 2056-14 2047-08 185715 185817 26C3-13 2137-09 15D9-17 15D9-18 2486-24 2489-30 2054-06 2054-10 26E0-18 2467-15 16J8-12 16J8-13 1871-07 2567-22 2367-13 2304-14 2304-15 2202-07 2288-10 1487-16 1488-03 1480-16 1488-04 2427-27 1857-13 2486-06 27J7-03 27Z0-17 27Z0-18 27Z0-19 2494-30 2071-34 2576-22 26E4-06 1124-05 1124-06 1132-03 1132-04 16K5-06 2493-18 2497-12 2848-14 2848-15 2842-01 2848-12 2896-03 2263-13 2263-14 2050-29 2547-29 2550-19 2058-17 2058-20 2054-07 2054-08 2328-05 2439-13 1535-09 2548-03 184826 2497-13 2039-09 2061-35 1905-11 0753-22 1685-16 1570-14 2135-17 2140-11 2493-28 2493-29 2850-09 2850-10 2581-07 2581-22 1867-14 27P6-19 15S2-19 26G7-24 26G7-25 26H3-28 2108-36 192717 2493-23 2494-21 1225-14 2822-20 2824-01 2585-04 1910-02 2540-23 2540-24 1694-19 2104-01 2047-36 0884-01 1991-18 2389-18 2107-29 2108-27 26D6-03 26D5-22 1174-08 2189-02 2189-03 2086-13 2086-21 2446-13 1557-12 2486-23 2867-03 191007 2137-14 16K5-12 16K5-13 16K5-14 16K5-15 2104-02 1725-20 26E4-04 26A9-09 2869-20 16Z2-20 2581-26 2389-13 1142-15 2075-40 0817-20 1927-15 1156-01 1160-04 1156-02 1156-09 1160-06 1331-10 1331-11 1331-12 2072-34 1548-08 2262-18 2405-26 16M8-03 16R5-08 15B7-12 15D2-01 15D2-02 15D2-03 16P2-20 2720-20 2451-02 2451-06 2451-09 2468-18 1985-12 1860-15 2850-03 2850-04 2067-31 2086-28 0829-17 191305 2107-11 1848-01 1848-03 27Z0-15 2704-19 2047-39 0884-04 1421-11 2423-16 2423-17 1482-12 28E7-02 2413-02 2413-03 2486-05 2074-17 2486-04 2486-16 2327-23 2398-05 2438-15 2438-16 2479-09 2479-11 2311-07 2311-11 2425-11 2427-18 2227-07 2233-16 27X4-18 2427-21 2381-03 2382-04 2822-19 2867-07 2850-01 2382-06 2227-02 26C7-30 14H8-04 1017-06 1021-03 1021-05 2108-31 2108-32 2414-14 2367-11 2367-12 2451-19 2406-28 27M5-12 2368-20 2369-01 2398-14 26G4-01 26G4-09 1686-01 2369-05 16S0-01 2080-19 1874-06 26D8-26 26E4-14 26D5-24 26D4-26 26D4-27 2039-07 2585-27 26A4-26 2570-30 13A9-09 2240-13 2240-15 1914-18 2072-31 2072-18 2304-13 2362-19 1122-18 1924-13 2049-14 16R5-15 27L8-11 1868-08 2446-12 2535-20 28E7-16 2548-24 1387-17 1486-20 1490-17 14A3-04 14A3-05 14A3-06 14A3-07 1118-13 2534-05 2534-06 1872-12 2047-37 0884-02 2413-09 2891-15 26H1-28 2858-02 16J8-16 16J8-17 16K2-01 27P2-10 2704-20 2441-10 2441-11 2422-18 2425-12 2219-18 2234-07 1988-11 26B5-23 2379-13 2406-29 2407-04 2894-20 2896-01 1919-05 2102-31 1872-07 1476-03 1479-07 2576-21 185503 27S2-18 2228-15 1005-29 2413-11 2429-30 1263-20 27P2-16 27P2-17 2108-05 2108-21 2425-14 2039-13 2041-16 2413-06 26F1-17 27S4-04 27S4-05 2585-19 2585-21 2493-05 2493-19 1910-04 2422-29 26D6-02 26E0-16 2842-11 2107-31 2848-18 2193-39 27R3-06 27R3-08 27L1-09 2842-10 1914-20 0763-09 2347-15 2348-16 27Z8-08 1691-15 2427-25 2427-26 2207-08 2226-09 26C7-29 14H8-03 2577-02 2577-01 26D4-29 26D4-30 1927-09 2848-16 1459-12 1459-13 1476-05 1476-06 2073-10 26C3-07 190703 2049-21 2369-03 2587-10 2305-22 2070-21 27J7-09 2066-27 2103-40 26H3-26 2848-19 2061-36 0801-27 2581-23 2584-23 2584-30 2395-29 2396-02 1870-16 2073-38 2080-30 2578-24 13B8-11 2071-20 2071-21 2065-04 27W3-18 1344-01 1344-07 1344-08 2288-12 2288-07 27Z8-18 27Z8-19 28E7-13 28E7-14 2140-06 2140-07 2257-02 2079-30 16P1-10 1479-08 1476-07 1476-08 1476-09 1476-10 1988-02 2137-17 14A9-01 14A9-05 2563-30 27R8-19 15S9-19 26B4-26 27J7-02 26H6-26 27Y6-16 27S0-18 27S0-19 26D9-30 2473-07 2486-21 27M5-14 2368-03 1128-16 2319-06 28A3-02 2363-01 26H5-28 28D3-18 1122-20 14M7-18 1616-18 16X4-19 2711-01 2232-19 2708-15 26D6-04 26D8-24 1872-15 1873-05 2054-11 2193-11 2140-03 1855-33 1927-06 1927-20 2074-15 2107-07 2074-14 2209-20 2078-16 2085-33 2137-11 2347-16 1914-17 2358-18 1914-15 0763-06 1118-12 0763-04 15F5-15 15F5-16 2077-38 2078-20 15H2-05 16K4-05 2074-30 2408-22 2580-28 2580-29 1679-13 2497-02 2497-03 26A9-06 1138-10 1139-01 1127-08 1138-08 16M7-05 1988-06 2148-15 28E5-13 2486-27 2493-04 1912-20 0761-08 2374-11 1684-07 1684-08 1570-17 1479-06 1480-17 15F5-12 15F5-13 15H2-08 15H2-09 15D9-15 15D9-16 1691-19 1548-16 2126-08 15H7-15 15H7-16 15H7-17 15H7-18 2068-33 1857-12 2850-15 2106-17 2858-03 2858-04 27P2-07 27P2-08 26D8-20 1418-03 1418-04 1561-12 1925-04 16P4-11 16P4-12 16P4-16 16P4-17 16P4-18 2187-36 2187-37 2187-38 2331-01 2085-09 2086-17 2086-18 2086-15 2086-16 2086-19 2188-08 2188-09 2188-10 2188-36 2188-37 2188-38 2102-06 2102-07 2102-08 2253-16 2253-17 2253-18 2260-11 2260-12 2260-13 26H6-24 2493-27 1858-04 1681-09 1860-21 1861-24 2065-10 1860-20 1860-17 2050-04 2566-26 27P0-20 2850-16 16K6-11 16K6-12 16K6-13 16K6-14 16K6-15 16K6-16 2061-20 2085-12 2085-14 2283-15 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2189-39 2251-16 2251-17 2251-18 2452-01 2469-06 2232-18 2234-02 26C3-08 26C3-09 2488-02 2232-20 2039-10 1357-15 1357-16 1357-17 1357-18 26G8-08 27R8-20 15S9-20 2493-13 2493-15 2469-05 2469-07 2234-01 2348-17 2145-17 2850-12 2850-13 2145-11 2145-12 15D3-13 15D5-04 15D5-06 15D6-17 1308-35 1308-36 1419-12 1422-17 16J8-14 16J8-15 2079-18 2081-12 2192-18 2147-05 2147-06 2085-05 2085-07 2085-08 2190-14 2188-01 2119-14 28D7-19 1616-19 1921-01 1921-02 1537-17 1905-01 1905-02 2050-03 2050-05 15E3-04 15E3-05 15E3-06 15E3-01 15E3-02 15E3-03 2085-16 2085-17 2189-01 2189-05 2189-06 2256-01 2278-09 2081-06 2188-05 2188-06 2188-07 2190-17 2190-18 2190-21 2190-03 2190-04 2190-05 2189-40 2190-01 2190-02 2189-36 2192-24 2086-12 2106-28 2106-29 2110-09 2110-10 2188-02 2119-13 2056-21 2147-04 2251-15 2253-12 2253-13 2253-14 2257-05 2257-06 2257-07 2059-05 2140-08 2140-10 2473-02 2473-03 2076-22 1544-10 1733-18 1725-19 1857-27 1556-12 1681-08 1694-20 16M6-20 16M7-02 16M7-03 16M8-04 2076-19 2076-20 2076-21 2083-03 2085-18 2083-02 2085-13 2275-14 2275-15 2275-16 2278-07 2190-13 2190-15 2190-16 2192-28 2192-29 2290-05 2290-06 1711-16 2192-12 2189-04 2086-14 2086-20 2190-10 2190-19 2190-20 26E4-12 26H6-23 27L7-20 2069-01 2087-03 26D8-21 26D8-25 2873-01 2891-18 1921-03 1557-10 1736-07 1855-12 1905-03 1925-03 16J8-07 16J8-08 16J8-09 16J8-10 16J8-11 2080-03 2085-15 2252-04 2252-03 2278-08 2079-19 2080-01 2081-04 2190-06 2190-07 2190-08 2190-09 2190-11 2190-12 2192-25 2192-32 2252-02 2253-15 2251-19 2251-20 2283-16 2296-20 27S8-10 27S4-06 2486-14 2486-15 27R3-20 27R5-01 2869-18 16Z2-18 2107-04 2485-29 2487-28 2587-12 2145-08 2290-12 2486-02 2062-02 2467-03 2066-22 2066-23 2102-36 2708-19 2719-08 27R3-05 1556-16 1861-23 2581-21 2066-35 2066-36 26G4-18 26G4-11 26G7-22 26C9-13 26C9-14 2070-15 2472-10 2481-09 2195-36 1160-01 1160-05 1183-04 1217-09 1225-11 26E4-11 2212-19 2212-20 1864-17 1864-18 2427-13 2431-26 26D6-06 14A8-02 16L5-02 16L8-01 16L8-02 16L8-03 16P4-10 27M5-15 2399-09 2399-13 2399-04 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2566-30 2486-07 2402-28 2226-16 2226-18 26D6-11 26D8-28 2585-25 27M5-11 26A4-23 26A4-29 26A5-01 2587-13 26D0-25 26D0-26 26D5-30 26D9-25 26E0-14 26G4-13 2585-20 2432-29 2432-30 2432-24 1211-19 1211-04 1211-05 1335-08 1335-09 1335-10 1335-11 1910-06 2438-14 27L1-05 2077-40 2078-21 2535-12 2535-13 2535-14 2550-12 2550-14 2565-25 2565-26 27J6-19 2550-15 2564-23 2565-24 2108-30 14B1-03 14B1-04 2423-03 26B4-22 2072-40 2107-38 2229-12 2233-20 2450-17 2451-01 2446-17 2446-19 2406-25 27Z0-12 27P6-16 27P8-01 16R0-06 16R5-06 2581-14 2581-15 2706-01 2493-25 2867-09 2871-19 27R1-16 2355-01 2485-28 1931-09 2039-11 2224-17 2473-04 2473-06 2486-17 2714-09 2714-10 2458-23 1387-16 26F3-20 26G4-12 2581-17 2437-18 27J6-17 2486-13 27Z6-18 27Z6-19 2472-08 2472-09 27S2-15 2720-16 16X4-16 26G4-10 16K3-11 16K3-12 16K3-13 26H3-25 2427-16 2427-17 26H5-29 14M7-19 2396-18 2321-23 2321-24 2362-20 1122-19 1146-01 1146-02 1146-03 16K3-10 2071-40 2219-17 2229-14 2535-06 2535-07 27W3-19 27W3-20 2398-15 2398-16 2407-06 26D4-28 26D8-22 2256-17 26D0-21 26D1-30 2061-29 1139-06 1139-07 15H2-11 15H2-12 15H2-14 2585-06 28E7-12 28F7-02 1132-05 1132-10 1137-02 2423-21 2425-13 26H0-30 14M0-20 2350-04 2408-23 2409-23 2432-25 1924-12 1935-17 2073-37 2042-03 2497-11 2140-12 2704-16 27L1-15 2220-06 2444-07 26F0-18 2080-25 2106-10 28E9-12 28F5-13 16R5-07 14B1-07 15B7-07 15B7-13 2842-14 2842-15 1853-03 1860-16 1733-16 1736-03 2070-01 2070-02 1601-03 1705-20 1208-05 1211-07 1211-08 2330-20 2409-24 2409-25 2107-18 1139-08 1139-10 1140-07 1140-10 1140-08 1156-06 1158-09 1156-07 14B3-08 14B3-09 14B3-10 2369-02 2564-21 2564-22 2227-09 1572-20 1673-01 27Y6-11 27Z0-06 27Z0-11 2413-12 2413-13 1928-01 1848-04 1925-08 1909-09 1909-10 1926-03 2567-23 2423-05 1936-10 1171-10 1211-13 1988-12 1983-06 2494-22 2054-09 1563-04 26B4-21 16K7-12 16M7-06 2856-19 2869-17 2856-20 16Y8-19 16Z2-17 16Y8-20 16L3-20 16K7-11 1866-13 2427-30 2428-01 26A5-08 26A9-03 2304-30 2305-08 2137-06 2564-29 1984-01 2384-19 26A4-24 26A4-25 2048-06 2048-29 2050-28 2072-19 26D6-07 26D6-08 26D6-10 15F0-14 15H2-06 15H2-07 15H5-01 2423-22 2867-05 2867-06 2894-07 2867-12 2894-10 2894-11 16K5-16 16K5-20 16M7-07 16M7-08 2867-13 2585-05 2585-26 2145-14 2145-15 2080-26 27X4-19 27X6-01 2398-17 2396-01 26A9-07 15H4-08 15H4-18 15H5-02 15H5-03 16K5-17 16K5-19 2069-08 2070-05 2313-17 2871-20 16R5-09 16R5-10 16R5-11 27L8-13 1992-19 1999-16 1999-17 2550-10 2550-11 1865-05 1908-10 0757-07 2867-10 16P1-06 16P1-07 16P1-08 16P1-09 2306-02 2306-03 1159-17 1159-18 27P2-05 1927-08 2219-20 16J9-20 1611-20 2312-26 2312-28 2444-08 1987-12 28F5-17 2493-08 2497-17 2422-17 26G4-16 2137-16 2896-02 27P2-04 2079-27 2079-36 2565-27 2567-21 2074-04 2074-01 2538-29 15B7-05 15B7-09 15B7-10 26B3-29 1991-07 1860-23 1871-11 2059-11 27L1-14 27Z8-13 2550-04 2896-05 2060-25 2066-39 26D5-28 16M7-19 16M7-20 1173-01 1985-06 2842-13 27Z8-04 27Z8-05 1919-07 1919-08 2560-03 13A1-02 2256-16 1919-03 1911-15 2050-31 2050-32 1909-08 2074-13 26G4-15 27Y6-15 27Y6-18 2842-17 2858-01 2188-03 26G4-17 2497-22 2538-28 1156-05 1158-10 1461-01 1461-02 1870-06 1870-14 2429-29 1263-19 2071-24 1469-01 1480-18 1925-12 1926-02 1548-17 1845-15 198703 1987-04 1159-20 15D9-20 15D9-19 2145-09 2145-10 2148-16 27Y6-10 27Z0-05 2218-14 27J7-08 2869-19 16Z2-19 2894-14 2137-18 2149-14 2585-24 2384-20 2385-01 27X6-05 2347-09 2347-10 2358-17 1118-11 26C3-14 26C3-20 2708-17 2708-18 2234-03 1156-08 1156-10 1344-09 27Y6-17 27S0-17 27Y6-13 27X4-15 26H4-29 27S2-11 27S2-12 2066-38 1867-20 1868-01 2047-09 2086-35 2369-06 2720-18 16X4-18 1987-14 1874-05 1985-08 1985-10 2494-28 2497-21 2064-06 2067-29 2472-19 2321-21 2195-03 1714-18 26B4-24 26B4-25 2495-02 2543-03 2543-08 2543-09 26E0-22 27Z0-13 2048-32 27S2-02 27S2-03 2704-18 2719-03 1208-08 1208-09 1211-02 1211-03 2367-14 2367-15 2059-10 27S2-04 27S2-08 27R5-02 27R3-18 2051-32 2896-06 2894-13 2058-32 27Y6-12 27S2-13 2102-33 2219-19 2225-01 2234-06 2224-15 2224-16 15C9-09 2229-10 2233-19 2233-13 2234-04 2496-21 1871-03 2382-07 2382-12 2403-21 2493-24 26H3-27 2848-11 26D8-19 26D8-27 2479-08 1601-02 1858-05 2317-18 2332-11 2332-12 2396-13 2398-06 2312-27 2332-20 26D0-24 1853-02 1855-10 1855-11 1858-02 1858-03 1849-02 1853-01 1691-14 1860-12 1860-13 1860-14 1860-11 2104-21 2104-03 2368-04 1128-17 2070-22 2581-19 2581-20 27J6-20 27X4-16 27X4-17 2850-07 2850-08 1146-05 1146-06 1147-04 1485-11 2067-30 2070-40 2414-10 2414-11 2414-12 2427-22 2430-28 2431-24 2431-25 26D9-29 26E4-09 2850-11 28B6-19 1611-19 2192-16 27Z8-10 27Z8-11 26G4-19 2858-05 2860-20 2368-13 2369-13 2304-12 1131-08 1132-01 1132-02 15J6-10 2144-13 2140-04 2894-09 2894-16 2894-17 1983-09 27Z8-15 2822-11 28D7-20 28F5-18 2432-27 1862-27 2719-09 2304-29 2305-09 2566-28 2566-29 2073-09 2059-40 2422-23 2422-24 2149-13 2430-30 2431-21 2431-22 2108-25 2108-26 1988-14 2494-27 2209-09 2209-10 26B6-29 14G5-05 2072-28 27J7-05 26G7-21 2073-40 27Z8-17 2848-13 26F0-30 2534-04 2534-03 2535-09 2535-10 2535-11 2405-28 2405-29 26B3-28 2544-22 2550-18 2488-04 27W5-01 1338-12 1338-13 1338-14 2202-11 2292-17 143115 2209-19 2327-26 1988-10 2056-09 2056-12 1559-13 1539-13 1539-14 1571-12 1480-19 1490-09 1490-13 1490-14 1491-01 15B7-08 28F5-14 2468-17 28E7-15 2432-22 2432-23 190520 2149-12 2104-08 2104-20 1867-16 1156-04 2444-14 1868-02 2423-04 2535-05 2192-13 2196-03 2497-15 2422-16 2137-03 2137-04 1698-05 1711-17 1991-13 1991-14 2233-17 2233-18 2543-11 2543-12 1544-06 26F1-18 26H6-28 26G4-14 2071-23 27Y6-14 2422-28 2423-20 2056-10 2056-13 2581-24 2585-23 2086-36 2108-37 2047-38 0884-03 16L7-18 16P4-01 2085-30 2087-11 26F0-28 26F1-16 27X8-20 15V4-20 2321-22 16P1-12 16P3-02 16P3-03 1865-19 1999-20 1861-20 15H7-19 15H7-20 15H8-01 15H8-09 15H9-13 15H9-14 15H9-15 15H9-16 15J0-03 15J0-04 15J0-06 15J0-08 16K4-01 16K4-02 16K4-03 16K4-04 16K5-07 16K5-08 2267-20 2262-19 2262-20 2221-03 199902 2414-09 2535-08 2385-02 2385-03 2327-12 2867-02 2427-14 2427-15 2234-08 2234-09 2236-10 1008-10 16K6-20 16K7-01 16K7-02 16K7-03 2486-12 2389-16 1142-18 1461-05 1468-18 1468-19 1468-20 2330-16 2330-18 1171-07 1171-08 1171-09 1173-10 1160-08 1171-06 1174-06 1174-07 2275-11 2278-10 2278-11 2330-19 2140-02 2262-17 2267-17 2267-18 2283-17 2330-17 2585-01 2585-02 2585-03 2585-16 2585-17 2399-05 2399-07 2233-15 2891-19 2079-29 15G9-03 15G9-04 2494-29 26G3-30 27J7-12 2305-10 1142-09 1145-10 26E0-20 26E0-21 2293-05 1140-01 2052-05 26D5-23 2196-07 1858-35 26D0-22 26D0-23 2192-09 2322-08 2107-22 2107-23 2190-38 2195-10 2402-29 2195-01 2103-36 2321-29 2066-28 1139-09 1173-08 2070-07 2310-08 1334-15 1335-13 1459-14 14B2-14 2488-03 1428-07 1182-08 1211-06 1331-13 1338-15 1338-16 27S2-14 1147-05 1149-01 26C7-28 14H8-02 1926-04 2432-26 2432-28 2566-27 26E4-13 15J6-02 15J6-08 2427-28 2037-13 2059-12 2058-18 2429-28 1263-18 2148-14 2149-08 2149-20 16P6-19 16R7-03 2256-02 2076-18 2262-16 2414-13 2891-16 2891-17 2148-09 28E7-18 2086-31 0829-20 2894-18 2894-19 1601-01 1698-03 16P6-14 2058-23 1429-13 2250-01 2307-05 1919-02 1919-04 2220-02 2220-04 1469-02 2220-07 26A5-02 2850-14 2431-23 2471-20 27K0-06 1211-20 15B7-06 27R3-09 27R3-13 1907-02 2321-20 2438-04 2409-22 2408-20 15C8-11 14B1-05 14B1-08 2332-10 2438-13 26E0-15 2037-11 1991-17 1991-16 26H6-27 2061-40 0802-01 199010 27Z0-08 15R8-20 27J6-14 27J6-13 27J7-01 27J6-18 27Z8-07 27P2-09 2479-10 2493-17 26D5-21 2850-02 27X6-06 27Y6-09 187018 1925-13 27Z8-06 2488-01 26F1-21 2708-16 27Z8-14 2042-02 2321-27 26A9-10 27L1-12 27L1-13 27L1-03 27L1-04 27K9-16 27L1-01 27L1-02 1983-08 1868-14 2288-08 2328-02 2473-01 2077-36 1928-02 1924-11 2192-11 1149-07 1149-08 1156-03 1167-02 16R0-07 16R0-08 1863-05 27J7-11 27J9-12 27L1-06 1935-16 26G4-08 15C9-08 27L1-07 27L1-08 15C8-12 15C8-13 15C8-14 15C8-15 27L1-10 27L1-11 2301-05 2308-06 2229-03 2229-07 2067-33 27S2-16 27Z8-16 1698-06 1733-17 26D5-27 26E0-17 1862-16 27J6-16 1538-10 27Z2-09 2494-23 2494-24 2494-25 2494-26 28F5-15 28F5-16 16R5-04 16R5-05 2061-34 2064-05 2137-05 2227-12 2227-13 2413-10 2422-15 2226-19 2233-14 1016-05 1017-01 2102-04 2102-05 27R3-14 27R3-16 2578-23 13B8-10 2708-20 27Z6-20 2867-04 2486-22 16L8-08 16M4-14 16M4-15 16M4-16 16M7-04 2550-16 2563-29 1905-06 2848-10 2842-04 2061-37 2061-38 0801-28 0801-29 2413-07 2422-19
Root Cause
Software design
Action Taken
Roche sent an Urgent Medical Device Correction (UMDC) sent via UPS Ground (receipt required) dated July 6, 2017, and an amended UMDC on August 31 ,2017. All consignees will be notified by Urgent Medical Device Correction sent via UPS Ground (receipt required). Customers/consignees were instructed the following: If the Tip/Cup pick up error alarm is issued then followed by the Abnormal L2-line Movement alarm on your MODULAR ANALYTICS E 170 module, cobas e 601 analyzer, or cobas e 602 analyzer, after which the system goes into Sampling Stop, follow the steps in this UMDC and the appropriate How to Identify Potentially Mismatched Sample Results within the enclosed document. For further questions, please call (317) 521-4343.