BEUDAMED
    FDA Recall Terminated

    HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320

    Recall: Z-0516-2014 · Initiated November 15, 2013

    Recall

    Recall Number
    Z-0516-2014
    Event Number
    66894
    Firm
    Instrumentation Laboratory Co.
    FEI Number
    1217183
    Product Code
    GGN
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    November 15, 2013
    Posted
    December 16, 2013
    Terminated
    March 25, 2014
    Address
    180 Hartwell Road, Bedford, MA, 01730-2443

    Description

    HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320

    Reason

    HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval

    Action

    Instrumentation Laboratory issued Important Correction Notice via USPS to US customers dated November 2013 advising users in the US that unassayed controls are not acceptable for use in their unassayed (non-value assigned) format. IL will no longer sell or distribute controls without assayed values for the US market as of November 15, 2013, and are converting US customers to an assayed control format. Additional contact with customers via phone calls and a reminder email. An enclosed response tracking form provided to be returned. For technical questions, contact the IL Technical Support Center at 1-800-678-0710, Option # 6 (ACL Coagulation Products). For replacement product if value assignments are not available for your product lot, please contact your IL Customer Service Representative at 1-800-955-9525, Option # 6. For questions regarding this recall call 781-861-4467.

    Distribution

    Nationwide Distribution

    Quantity

    84561 kits