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.
FDA Recall Z-0047-05 · Posted 2004-10-28
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Recalling FirmPerkinElmer LAS Inc
Recall StatusTerminated
Product CodeGKA
Date Initiated2004-09-14
Date Terminated2008-10-29
Product QuantityAll lots of test kits manufactured by the firm which have an active shelf life are subject to recall.
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.
Firm Action
The firm contacted their consignees by letter dated 9/14/04.
Root Cause
Other
Distribution Pattern
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).
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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