BEUDAMED
    FDA Recall Terminated

    Architect LH MasterCheck (List 6C25-05). An in-vitro diagnostic, consisting of 4 - 2 mL vials of LH MasterCheck, Levels 0, 1, 2 and 3. Manufactured for Abbott Laboratories, Abbott Park, IL 60064. ARCHITECT LH MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the LH assay on the Abbott ARCHITECT i System.

    Recall: Z-0216-2009 · Initiated September 5, 2008

    Recall

    Recall Number
    Z-0216-2009
    Event Number
    49427
    Firm
    Abbott Laboratories
    FEI Number
    1415939
    Product Code
    JJX
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    September 5, 2008
    Posted
    November 13, 2008
    Terminated
    March 18, 2010
    Address
    100 Abbott Park Rd, Abbott Park, IL, 60064-3502

    Description

    Architect LH MasterCheck (List 6C25-05). An in-vitro diagnostic, consisting of 4 - 2 mL vials of LH MasterCheck, Levels 0, 1, 2 and 3. Manufactured for Abbott Laboratories, Abbott Park, IL 60064. ARCHITECT LH MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the LH assay on the Abbott ARCHITECT i System.

    Reason

    The values listed in the Architect LH MasterCheck, Lot 82520 data sheet are incorrect. When MasterChecks do not perform as intended, the integrity of the system cannot be verified and patient results would not be generated. Other commercially available materials are available to customers in order to meet CLIA requirements.

    Action

    A Product Correction, Immediate Action Required letter and Customer Reply Form dated 9/5/08 were sent to all Architect LH MasterChecks (List Number 6C25-05) customers who received Lot 82520M. Customers were informed that the values listed in the Architect LH MasterCheck Lot 82520 data sheet are incorrect. Customers were requested to check their inventory for the affected lot, and if any kits were found, to substitute the values printed on the data sheet with the values supplied in the letter. In addition, Customers were requested to keep a copy of the letter on file and to complete the Customer Reply Form, indicating that the letter was received, understood and disseminated to the laboratory manager/supervisor responsible for the Architect LH MasterCheck testing, and fax it to Abbott by 9/19/08 at 1-800-777-0051. Follow-up telephone calls will be placed to customers who do not provide a written reply via the Customer Reply Form. U.S. Customers please contact Abbott Laboratories Customer Service at 1-877-422-2688 for questions regarding this information.

    Distribution

    Nationwide Distribution including Arizona, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Missouri, Montana, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah and Virginia.

    Quantity

    30 kits