pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test parameters include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMPH %/#, MIXED %/# (EO, BSO, MONO).
- Company
- Sysmex America Inc
- Recall Initiated
- May 15, 2013
- Posted
- October 18, 2013
- Terminated
- August 15, 2016
- Recall Number
- Z-0100-2014
- Quantity
- 193 units
- Firm Location
- Lincolnshire, IL
Reason for Recall
The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.
Distribution
Worldwide distribution: US (Nationwide) including Puerto Rico and states of: AK, AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and country of Canada.
Lot / Code Info
Product Code: 023-1861-8; Serial Numbers: B1677 - B1826, F1827 - F2161, F2178 - F2198, F2216 - F2396, F2411 - F2452, F2464 - F2472, F2495 - F2523, F2533, F2550 - F2560, F2592 - F2601, F2614 - F2635, F2640 - F2648, F2662 - F2679, F2710 - F2853, F2855 - F2871, F2878 - F2922, F2945, F2946, F2962 - F2970, F2998 - F3008, F3072 - F3080, F3083 - F3098
Root Cause
Nonconforming Material/Component
Action Taken
The firm, Sysmex, sent a "Product Notification-FIELD CORRECTION" letter dated May 2013 to all customers in the U.S. and Canada on May 15, 2013 by U.S. Mail. The letter describes the product, problem and actions to be taken. The customers will be contacted by a Sysmex Service Representative within the following 90 days to schedule an appointment to replace the Printed Circuit Board (PCB) on the internal printer. The repair will be performed during an on-site service visit. The customers were instructed to, until the repair can be made, use the thermal printer for reporting results; to compare the sample identification, values and decimal points on the printout with the data on the LCD screen for accuracy. If you have any questions concerning this information, please email the Sysmex Technical Assistance Center (TAC). Simply click on email TAC button on the home page of the CRC, complete the form that appears and then click the submit to send your question to TAC. Sending an email to TAC is recommended for non-urgent requests. For urgent request, call the Technical Assistance Center at 1-888-879-7639.