BEUDAMED
    FDA Recall Terminated

    MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Urine Combo 55; Catalog Number B1017-409. Siemens Healthcare Diagnostics, West Sacramento, CA.

    Recall: Z-1497-2012 · Initiated June 16, 2011

    Recall

    Recall Number
    Z-1497-2012
    Event Number
    61610
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2919016
    Product Code
    JWY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 16, 2011
    Posted
    May 8, 2012
    Terminated
    May 8, 2012
    Address
    2040 Enterprise Blvd, West Sacramento, CA, 95691-3427

    Description

    MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Urine Combo 55; Catalog Number B1017-409. Siemens Healthcare Diagnostics, West Sacramento, CA.

    Reason

    Three lots were confirmed to not meet performance claims due to random non-biological contamination which is only apparent (precipated) after inoculation of the panels.

    Action

    Customer Notification letters were sent to all customers of the three MicroScan panels by traceable mail. The letter identified the affected product and asked customers to discard any remaining inventory in addition to contacting customer service for replacement product. The letter also recommended that customers consider the need to review previous test results, conduct patient follow-up, and or repeat tests as needed. Customers were to complete and return the customer reply card to confirm that they received and understood the recall communication.

    Distribution

    Worldwide Distribution -- US, Turkey, Poland, and Great Britain.

    Quantity

    687 boxes (20 panels per box).