Reported Jan 28, 2015 · Terminated
PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG…
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?
PF4 Concentrated Wash (10x)REF 403624
- packaged in the following assay kits1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and 2. ImmucorGamma LIFECODES PF4 Enhanced (catalog numbers X-HAT13, X-HAT45) The PF4 IgG assay is an Enzyme Linked Immunosorbent Assay (ELISA). The PF4 IgG ELISA is intended to detect IgG antibodies in human serum that react with Platelet Factor 4 (PF4) when it is complexed to heparin or other polyanionic compounds. The PF4 IgG kit contains all of the reagents necessary to perform the assay
- Lot codes and dates
- Reagent Lot Numbers
3001620300198730020833002153
- Reagent Lot Numbers
- Amount recalled
- 6206 kits
Where it was sold
Why it was recalled
Some Lots of PF4 Concentrated Wash (10X) are a slightly more dilute concentration. This may lead to slightly increased Optical Density (OD) values. Samples with a higher background reactivity may demonstrate false positive result (borderline reactivity) at or near the cutoff for the assay.
This product could cause temporary or reversible health problems — stop using it.
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