Recall Z-1930-2012 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Alere San Diego, Inc.
Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens.
| Date | Jul 6, 2012 (initiated May 22, 2012) |
| Status | Terminated |
| Reason | Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing. |
| Root cause | Process design |
| Action | Phase 1 of the recall included a recall communication being initiated on May 22, 2012 with Alere forwarding a recall letter to all their customers who purchased the Triage CardioProfiler Panel, Triage Cardiac Panel, Triage Profiler SOB Panel, Triage BNP, and Triage D-dimer. The letter informed the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use of the affected product, and to complete and fax the enclosed verification form within 10 days. Phase 2 of the recall included a recall communication letter being forwarded to custome |
| Quantity | 5,013 kits |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080269 | TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS Biosite Incorporated, Jun 6, 2008 |