Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PF4 Concentrated Wash (10x) Recalled by Genetic Testing Institute,inc Due to Some Lots of PF4 Concentrated Wash (10X) are...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Genetic Testing Institute,inc directly.
Affected Products
PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. 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.
Quantity: 6206 kits
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Genetic Testing Institute,inc
Genetic Testing Institute,inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report