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Terminated

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.

FDA Recall Z-1001-2015 · Posted 2015-01-20

Recalling FirmGenetic Testing Institute,inc
Recall StatusTerminated
Product CodeLCO
Date Initiated2014-12-15
Date Terminated2015-04-30
Product Quantity6206 kits

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.

Firm Action

Immucor sent an Urgent - Field Safety Notice letter dated December 15, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised to stop using the recalled product and to destroy it. Requested consignees to complete the Customer Response From and return to [email protected]. Please contact Technical Support should you need additional information at 262.754.1000 or [email protected].

Root Cause

Employee error

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 )

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K053559PF4 ENHANCED SOLID PHASE ELISAGenetic Testing Institute · 2006-01-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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