Genetic Testing Institute,inc: Medical Device Recalls in 2015

Updated on March 25, 2026.

According to to data from the FDA, there was 1 medical device recall made by Genetic Testing Institute,inc in 2015. See the detail of the recall below.

You can see similar recalls for other firms.

Data Source: FDA.

See this for other years:

2013

2015

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.