BEUDAMED
    FDA Recall Terminated

    Multigent Vancomycin Calibrators; Manufactured by Microgenics Corp, Fremont, CA. Distributed by: Abbott Diagnostics, Abbott Park, IL Product Usage: The Multigent Vancomycin calibrators are intended for use in the calibration of the multiagent vancomycin Vancomycin is a commonly used antibiotic to treat staphylococcus and other gram-positive bacterial infections.

    Recall: Z-0297-2012 · Initiated June 8, 2011

    Recall

    Recall Number
    Z-0297-2012
    Event Number
    60233
    Firm
    Microgenics Corp
    FEI Number
    3010939897
    Product Code
    DLJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 8, 2011
    Posted
    November 28, 2011
    Terminated
    February 17, 2012
    Address
    46360 Fremont Blvd, Fremont, CA, 94538

    Description

    Multigent Vancomycin Calibrators; Manufactured by Microgenics Corp, Fremont, CA. Distributed by: Abbott Diagnostics, Abbott Park, IL Product Usage: The Multigent Vancomycin calibrators are intended for use in the calibration of the multiagent vancomycin Vancomycin is a commonly used antibiotic to treat staphylococcus and other gram-positive bacterial infections.

    Reason

    Complaint from the sole distributor that the third party control material is recovering high, and outside the published range.

    Action

    Microgenics sent a Product Removal notification letter dated June 15, 2011 to all affected customers. The letter identified the affected product, the problem, and the necessary actions to be taken. Customers were instructed to discontinue use and dispose of the affected product per local waste ordinances, review all patient results reported with the use of this lot, and retain a copy of this notification for their records. The letter states that if the affected product has been forwarded to another laboratory, a copy of the letter is to be provided to them. An alternative calibrator is available to customers impacted. It can be ordered by calling Thermo Fischer Scientific Customer Service at 1-800-232-3342. Questions regarding the information should be forwarded to Abbott Customer Service at 1-877-4ABBOTT.

    Distribution

    Nationwide Distribution (USA) in the state of ILLINOIS

    Quantity

    809 kits lot 59446762; 651 kits lot 59391741