BEUDAMED
    FDA Enforcement Class II Terminated

    Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control materials that are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are not used to calibrate the Triage tests. The results of quality control testing do not impact direct patient care and should not influence clinical decision making process the physician uses to make clinical diagnosis for the patient. Indications for Use: The Alere Triage Total 5 Controls are assayed materials to be used with the Alere Triage Cardiac Panel, Alere Triage CardioProfiler Panel, Alere Triage Profiler SOB Panel, Alere Triage BNP Test, Alere Triage D-Dimer Test, and Alere Triage Meters to assist the laboratory in monitoring test performance.

    Recall: Z-0588-2017 · Reported November 23, 2016

    Enforcement

    Recall Number
    Z-0588-2017
    Event ID
    75443
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alere San Diego, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 23, 2016
    Initiation Date
    October 12, 2016
    Classification Date
    November 16, 2016
    Termination Date
    July 24, 2017
    Address
    9975 Summers Ridge Rd, N/A, San Diego, CA, 92121-2997, United States

    Description

    Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control materials that are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are not used to calibrate the Triage tests. The results of quality control testing do not impact direct patient care and should not influence clinical decision making process the physician uses to make clinical diagnosis for the patient. Indications for Use: The Alere Triage Total 5 Controls are assayed materials to be used with the Alere Triage Cardiac Panel, Alere Triage CardioProfiler Panel, Alere Triage Profiler SOB Panel, Alere Triage BNP Test, Alere Triage D-Dimer Test, and Alere Triage Meters to assist the laboratory in monitoring test performance.

    Reason

    Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card.

    Code Info

    C3233A

    Distribution

    US Nationwide Distribution

    Quantity

    513 kits