BEUDAMED
    FDA Recall Terminated

    Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21 Clinical Chemistry Albumin BCG 510(k) K981758, Product Code CIX The Albumin BCG assay is used for the quantitation of albumin in human serum or plasma

    Recall: Z-1434-2012 · Initiated March 10, 2010

    Recall

    Recall Number
    Z-1434-2012
    Event Number
    55440
    Firm
    Abbott Laboratories Inc.
    FEI Number
    2018433
    Product Code
    CIX
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    March 10, 2010
    Posted
    April 18, 2012
    Terminated
    April 18, 2012
    Address
    820 Mission St, South Pasadena, CA, 91030-3142

    Description

    Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21 Clinical Chemistry Albumin BCG 510(k) K981758, Product Code CIX The Albumin BCG assay is used for the quantitation of albumin in human serum or plasma

    Reason

    Observed particulate matter in some reagent cartridges.

    Action

    Abbott Laboratories sent a Product Recall notification letter dated March 10, 2010, to all affected customers. The notification letter contained an explanation, patient impact, neccassary actions, and contact information. Customers were instructed to determine if they currently have any of the affected product in their inventory. Discontinue use and destroy any remaining inventory of the affected product in accordance with their institution's policies and procedures. Completed the enclosed Customer Reply Form. If customers forwarded any of the affected product they should provide a copy of the notification letter to their customers. For any questions customers should call Customer Service at 1-877-422-2688. For questions regarding this recall call 626-440-0705.

    Distribution

    US nationwide and internationally to Germany, Hong Kong, Australia, New Zealand, Trinidad/Tobago, and Jamaica. No dsitribution of Canada or Mexica.

    Quantity

    2718 (U.S. 652)