FDA Device

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.

Hazard

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.

What You Should Do

Remedy

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.

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Products

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 fai
Brand
Alere San Diego
UPC
Lot Code: W49569   Phase 2 (June 12, 2012): Lot#W49636

Units Affected

1080 kits

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