Recall Z-1466-2012 ยท MMI Immunoassay Method, Troponin Subunit
Alere San Diego
Alere Triage CardioProfiler Panel, PN 97100CP. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of congestive heart failure, an aid in the risk stratification of patients with heart failure, and as an aid in the risk stratification of patients with acute coronary syndromes.
| Date | Apr 26, 2012 (initiated Mar 5, 2012) |
| Status | Terminated |
| Reason | Alere San Diego, Inc. is initiating a voluntary recall of the Alere Triage CardioProfiler Panel PN 9700CP, Lot W49569 and the Alere Triage Profiler SOB Panel PN 97300, Lot W48990. Alere San Diego, Inc. has determined that these lots have an increased frequency of Troponin I results >0.05ng/mL for samples which are found to be below 0.05ng/mL upon additional testing. |
| Root cause | Process control |
| Action | A recall communication was initiated on 3/15/12 with Alere San Diego, Inc. forwarding a "Urgent Medical Device Recall" letter to all their customers who purchased the Alere Triage CardioProfiler Panel PN 97100CP, Lot W49569 and Alere Triage Profiler SOB Panel PN 97300, Lot W48990. The letter informed the customers about the problems identified and the actions to be taken. Customers with any questions about the information contained in this notification should contact Alere San Diego, Inc. at (877) 308-8287. |
| Quantity | 1080 kits |
| Distribution | Worldwide Distribution, including Nationwide (US) and the countries of Brazil, China, India and Kuwait. |
| 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 |