BEUDAMED
    FDA Recall Terminated

    MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 B1017-211 panels are 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-positive bacteria.

    Recall: Z-1524-2015 · Initiated April 8, 2014

    Recall

    Recall Number
    Z-1524-2015
    Event Number
    70904
    Firm
    Beckman Coulter, Inc.
    FEI Number
    2919016
    Product Code
    JWY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 8, 2014
    Posted
    April 27, 2015
    Terminated
    April 27, 2015
    Address
    2040 Enterprise Blvd, West Sacramento, CA, 95691-3427

    Description

    MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 B1017-211 panels are 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-positive bacteria.

    Reason

    Siemens investigation confirmed that a portion one lot of panel Pos Combo 33 lot was packaged without desiccants. The substrates on a panel packaged without a desiccant may deteriorate over time due to exposure to additional moisture in the panel pouch.

    Action

    Siemens sent an Urgent Medical Device Recall letter dated April 8, 2014, to all affected customers. Letters advised users of the recalled product with catalog number, Siemens Material Number and Lot number as well as the reason for recall. The risk to health was explained as well as the recommendation for discussing the content of the letter with the medical director regarding the need to review previous test results. Customers are asked to discontinue use and discard any remaining inventory of the PC33 panel 2014-09-12. All other lot numbers are not impacted. The attached confirmation receipt is to be completed and returned and the letter should remain with laboratory records. Questions should be directed to Siemens Customer Care Center. For further questions call (916) 374-3031.

    Distribution

    Nationwide Distribution including Puerto Rico and to the states of : CT, GA, NC, OK, NY, SC, KY, TN, CA, WA, OR, NJ, OH, PA, FL, MI, TX, WI, MO and NH.

    Quantity

    664 panel boxes