BEUDAMED
    FDA Recall Terminated

    Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.

    Recall: Z-1272-2013 · Initiated March 6, 2013

    Recall

    Recall Number
    Z-1272-2013
    Event Number
    64699
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2919016
    Product Code
    LTT
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 6, 2013
    Posted
    May 8, 2013
    Terminated
    October 28, 2013
    Address
    2040 Enterprise Blvd, West Sacramento, CA, 95691-3427

    Description

    Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.

    Reason

    Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. agalactiae affecting multiple antimicrobial agents on MicroScan Microbiology Systems.

    Action

    Siemens Healthcare sent a Urgent Field Safety Notification letter dated March 6, 2013, to all affected customers of MicroScan MICroSTREP plus type 1, who process panels in a Walk Away System. The letter identified the product the problem and the action needed to be taken by the customer. As stated in our product Instructions for Use, test results should be interpreted in conjunction with the patients medical history, clinical presentation and other findings. We recommend discussing the content of this letter with your laboratory director regarding the need to review previous test results, conduct patient follow-up, and/or repeat testing for testing conducted in the last twelve months. Confirmation of receipt of this letter is required. Attached you will find a form indicating you have received and understood the information. We would greatly appreciate your assistance in notifying us that you have received the information by taking a moment to complete and return the form below. If you require further information or assistance, please contact your local Siemens Healthcare Diagnostics Representative. Please forward this notification to anyone to whom you may have distributed this product. We apologize for the inconvenience that this situation has caused. For further questions please call 1-800-677-7226 Option 1 (USA/Canada) Thank you for your patience and continued support.

    Distribution

    US Nationwide Distribution including Puerto Rico.

    Quantity

    21,608 boxes = 432,160 panels