Reported Apr 3, 2013 · Terminated
Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked…
Genetic Testing Institute,Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Genetic Testing Institute,inc · 20925 Crossroads Cir Ste 200 · Waukesha, WI · 53186-4054
Is this the product you have?
- Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
- Lot codes and dates
- Kit Lot Number 3000389
- Amount recalled
- 386 kits (370 US, 16 OUS)
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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