Recall Z-1022-2013 ยท LCO Platelet Factor 4 Radioimmunoassay
Genetic Testing Institute,inc
Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
| Date | Mar 28, 2013 (initiated Feb 4, 2013) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Process control |
| Action | Hologic/Gen-Probe sent an Urgent Medical Device Recall letter dated February 4, 2013, via FedEx overnight deliver yto all affected customers. The letter identified affected product, stated the issue, and asked that product from the affected lot stop being used. Reported results for all samples tested using the affected lot should be reviewed. The referring physician should be notified that any negative patient result may be erroneous. Remaining inventory should be returned to Gen-Probe. A response form was also asked to be returned. For questions customers were instructed to contact Tech |
| Quantity | 386 kits (370 US, 16 OUS) |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain. |
| 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 |