BEUDAMED
    FDA Recall Terminated

    Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria

    Recall: Z-0844-2022 · Initiated March 3, 2022

    Recall

    Recall Number
    Z-0844-2022
    Event Number
    89746
    Firm
    Microbiologics Inc
    FEI Number
    2150138
    Product Code
    OHQ
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    March 3, 2022
    Terminated
    January 16, 2024
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440

    Description

    Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria

    Reason

    Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.

    Action

    Microbiologics notified customers on 03/03/2022 via letter titled "Urgent Medical Device Recall Re: 8244 Pneumonia (33 Targets) Control Panel". Instructions included to review lab procedures to understand how the information affects usage, discard expired product, complete the response form provided, return the response form to [email protected], and keep the letter for consignees' records. Questions or concerns can be directed to the Recall Support team at 320.229.7073 or [email protected].

    Distribution

    US distribution to Alabama, Georgia, Illinois, Montana, Pennsylvania, Tennessee, Texas, and Wisconsin

    Quantity

    13 units