BEUDAMED
    FDA Recall Open, Classified

    BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultative anaerobic gram-positive bacteria of human origin with selected antimicrobial agents when used with the BD Phoenix Automated Microbiology System. Catalog (Ref) Number: 448607

    Recall: Z-0232-2023 · Initiated October 13, 2022

    Recall

    Recall Number
    Z-0232-2023
    Event Number
    91010
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    LON
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 13, 2022
    Posted
    November 14, 2022
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    Description

    BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultative anaerobic gram-positive bacteria of human origin with selected antimicrobial agents when used with the BD Phoenix Automated Microbiology System. Catalog (Ref) Number: 448607

    Reason

    Misformulated minocycline-can cause erroneously increased Minimal Inhibitory Concentration (MIC) values when performing antibiotic susceptibility testing (AST) against minocycline and result in the reporting of false resistance for clinical samples if the initial Quality Control (QC) testing of the panel batch passes, delaying treatment of the patient with the most appropriate antibiotic

    Action

    BD initiated the recall on October 13, 2022 via Urgent Medical Device Product Advisory states reason for recall, health risk and action to take: 1. Immediately inspect your inventory for the specific catalog and lot number listed above and ensure the contents of this Product Advisory are read and understood. 2. It is recommended to suspend reporting of Minocyline AST results to clinicians for the affected lot. 3. Share and post this Product Advisory letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements. BD Contact US Contact Information Areas of Support North American Regional Complaint Center Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Recall when prompted Mon Fri 8:00am and 5:00pm CT or Email: [email protected]

    Distribution

    US Nationwide distribution.

    Quantity

    13,900 EA