BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1466-2012 · Initiated March 5, 2012

    Recall

    Recall Number
    Z-1466-2012
    Event Number
    61516
    Firm
    Alere San Diego
    FEI Number
    1000125596
    Product Code
    MMI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 5, 2012
    Posted
    April 26, 2012
    Terminated
    December 4, 2012
    Address
    9975 Summers Ridge Rd, San Diego, CA, 92121-2997

    Description

    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.

    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.

    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.

    Distribution

    Worldwide Distribution, including Nationwide (US) and the countries of Brazil, China, India and Kuwait.

    Quantity

    1080 kits