RESOLVE Hemoglobin Test Kits packed and distributed under the Perkin Elmer Life and Analytical Sciences label, Kit Codes: FR-9120 - 120 tests per kit; FR-9400 - 360 tests per kit; and FR-9360 - 3600 tests per kit.
- Company
- Perkinelmer Las Inc
- Recall Initiated
- September 14, 2004
- Posted
- October 28, 2004
- Terminated
- October 29, 2008
- Recall Number
- Z-0047-05
- Quantity
- All lots of test kits manufactured by the firm which have an active shelf life are subject to recall.
- Firm Location
- Norton, OH
Reason for Recall
The product insert for the test kits is incorrect with regard to the acceptable storage temperature for the Agarose IEF gel component. The kit and IEF gel labels indicate the correct storage temperature of 2-8 degrees C. The product insert incorrectly indicates that the product may be stored at 2-30 degrees C.
Distribution
Nationwide (The product was distributed to firms located in AR, AZ, CA, CO,FL, GA, HI, IA, IL, IN, KS, KY,LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV )and worldwide (to 12 foreign accounts).
Lot / Code Info
FR-9120 - Lot Number: 243309 FR-9360 - Lot Numbers: 213926, 213932, 213939, 213944, 220789, 220794, 220804, 220809, 220799, 220814, 220819, 220824, 220829, 220834, 220839, 220848, 220855, 220860, 220865, 220870, 220875, 220882, 220892, 220898, 228304, 228309, 228314, 228319, 228325, 228330, 228335, 228341, 228348, 228353, 228358, 228363, 228368, 228374, 228379, 228386, 228391, 228396, 229401, 228406, 234161, 234172, 234177, 234182, 234190, 234195, 234200, 234205, 234210, 234222, 234231, 234240, 234247, 234252, 234257, 234262, 238917, 234267, 234272, 234277, 238920, 238923, 238926, 238929, 238932, 238946, 238950, 238953, 238960, 238963, 242331, 242334, 242334. FR-9400 - Lot Numbers: 213941, 220791, 220901, 220806, 220811, 220801, 220816, 220826, 220831, 220836, 220841, 220857, 220862, 220902, 220872, 220894, 220900, 228306, 228316, 228327, 228332, 228344, 228350, 228355, 228360, 228365, 228376, 228381, 228388, 228398, 228403, 228408, 2234192.
Root Cause
Other
Action Taken
The firm contacted their consignees by letter dated 9/14/04.