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Z-1001-2015 Class II Terminated

Recalled by Genetic Testing Institute,inc — Waukesha, WI

FDA device recall Z-1001-2015 was initiated by Genetic Testing Institute,inc on December 15, 2014 and is designated Class II. Reason for recall: 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 demo… The recall status is terminated (terminated April 30, 2015). Affected quantity: 6206 kits.

Recall Details

Product Type: Devices
Report Date: January 28, 2015
Initiation Date: December 15, 2014
Termination Date: April 30, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6206 kits

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution - Nationwide Distribution to the states of : AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN,TX, UT, VA, WA, WV and WI., and the countries of : Canada, Japan, Belgium, European Union , Australia, Taiwan, Thailand and Scotland. ( some countries not yet identified )

Code Information

Reagent Lot Numbers: 3001620, 3001987, 3002083, 3002153