Alere Triage Profiler SOB Panel, PN 97300. The test is used as an aid in the diagnosis of myocardial infarction (injury)
FDA device recall Z-1467-2012 · posted 2012-04-26 · Terminated
Recall details
- Recalling firm
- Alere San Diego
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MMI
- Quantity affected
- 1,316 kits
- Distribution
- Worldwide Distribution, including Nationwide (US) and the countries of Brazil, China, India and Kuwait.
- Date initiated
- 2012-03-05
- Date posted
- 2012-04-26
- Date terminated
- 2012-12-04
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS (K080269) | Biosite Incorporated | 2008-06-06 |