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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Product Detail

Product Description Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
Recall Number Z-1022-2013
Classification Class II
Code Info Kit Lot Number 3000389
Product Distributed Qty 386 kits (370 US, 16 OUS)
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 patient. However, some kits from this lot may produce false negative results. A false negative result could contribute to a delay in diagnosis and initiation of alternative therapies, and may increase the risk of complications.

Event Detail

Event Id 64501
Product Type Devices
Status Ongoing
Recalling Firm Genetic Testing Institute,inc
City Waukesha
State WI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-04
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain.
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