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Genetic Testing Institute,inc Recalls
2 recalls on record · April 3, 2013 to January 28, 2015 · Medical Devices
Recalls by year
13
15
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 28, 2015Medical DevicesFDA
Genetic Testing Institute,inc recalls PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (cata
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.
April 3, 2013Medical DevicesFDA
Genetic Testing Institute,inc recalls Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-link
Hazard: 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