Recall Z-1001-2015 ยท LCO Platelet Factor 4 Radioimmunoassay
Genetic Testing Institute,inc
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
| Date | Jan 20, 2015 (initiated Dec 15, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Employee error |
| 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 waukeshatechsupport@immucor.com. Please contact Technical Support should you need additional information at 262.754.1000 or waukeshatechsupport@immucor.com. |
| Quantity | 6206 kits |
| Distribution | 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, Eu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053559 | PF4 ENHANCED SOLID PHASE ELISA Genetic Testing Institute, Jan 20, 2006 |