Alere Triage Profiler SOB Panel, PN 97300. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the risk stratification of patients with heart failure, an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism and an aid in the risk stratification of patients with acute coronary syndromes.
This recall has been terminated (originally issued April 26, 2012).
- Company
- Alere San Diego
- Recall Initiated
- March 5, 2012
- Posted
- April 26, 2012
- Terminated
- December 4, 2012
- Recall Number
- Z-1467-2012
- Quantity
- 1,316 kits
- Firm Location
- San Diego, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution, including Nationwide (US) and the countries of Brazil, China, India and Kuwait.
Lot / Code Info
Lot Code: W48990 Phase 2 (June 12, 2012): Lot#W50019, W50027
Root Cause
Process control
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.