FDADecember 15, 2014device
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 PF...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
genetic testing institutegeneticgenetic testing
Recall history
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- FDANatpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA 68875-0205-022019-09-12
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