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U.S. Department of Health and Human Services

Class 2 Device Recall LIFECODES PF4 Enhanced assay

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 Class 2 Recall
LIFECODES PF4 Enhanced assay
see related information
Date Posted March 28, 2013
Recall Status1 Open
Recall Number Z-1022-2013
Recall Event ID 64501
Premarket Notification
510(K) Number
K053559 
Product Classification Platelet Factor 4 Radioimmunoassay - Product Code LCO
Product Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
Code Information Kit Lot Number 3000389
Recalling Firm/
Manufacturer
Genetic Testing Institute,inc
20925 Crossroads Cir Ste 200
Waukesha, Wisconsin 53186-4054
Manufacturer Reason
for Recall
Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate values when testing the kit Positive Control and patient samples. The variation in reactivity can lead to invalid assays. If an invalid assay is obtained, those results should not be reported and the test should be re-run. An invalid assay would not result in significant harm to a pati
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Hologic/Gen-Probe sent an Urgent Medical Device Recall letter dated February 4, 2013, via FedEx overnight deliver yto all affected customers. The letter identified affected product, stated the issue, and asked that product from the affected lot stop being used. Reported results for all samples tested using the affected lot should be reviewed. The referring physician should be notified that any negative patient result may be erroneous. Remaining inventory should be returned to Gen-Probe. A response form was also asked to be returned. For questions customers were instructed to contact Technical Support at 262-754-1000 or waukeshatechsupport@gen-probe.com. For questions regarding this recall call 262-754-1026.
Quantity in Commerce 386 kits (370 US, 16 OUS)
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LCO and Original Applicant = GENETIC TESTING INSTITUTE
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