BEUDAMED
    FDA Recall Terminated

    MicroScan Synergies Plus Negative Panels, 20 panels per box Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-negative bacteria. Catalog Nos. B1016-200, B1016-201, B1016-202, B1016-203, B1025-103, B1025-104, B1025-105, B1025-106, B1025-107, B1025-108, B1025-109, B1025-112, and B1027-101

    Recall: Z-0541-2009 · Initiated July 31, 2008

    Recall

    Recall Number
    Z-0541-2009
    Event Number
    49114
    Firm
    Siemens Microscan
    FEI Number
    2919016
    Product Code
    JWY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 31, 2008
    Posted
    February 4, 2009
    Terminated
    November 29, 2010
    Address
    1584 Enterprise Blvd, West Sacramento, CA, 95691-3422

    Description

    MicroScan Synergies Plus Negative Panels, 20 panels per box Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-negative bacteria. Catalog Nos. B1016-200, B1016-201, B1016-202, B1016-203, B1025-103, B1025-104, B1025-105, B1025-106, B1025-107, B1025-108, B1025-109, B1025-112, and B1027-101

    Reason

    Falsely lowered imipenem MICs may result, leading to major errors in results.

    Action

    Consignees were notified on July 31, 2008 by letter (Urgent Device Correction) sent via FedEx overnight. International consignees were notified by Siemens Healthcare Diagnostics associates in affected countries. The letter described the problem and provided users with safety instructions to follow until an update is provided. Contact Siemens Healthcare Diagnostics Inc. at 916-374-3075 for additional assistance.

    Distribution

    Worldwide

    Quantity

    Total of both Negative and Synergy: 569,375 boxes