BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDNOW STREP A KITS

    MDR report key: 24742158 · Received March 31, 2026

    Report

    Report Number
    MW5186153
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    March 20, 2026
    Report Date
    March 27, 2026
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    OOI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE WHITE TRANSFER CARTRIDGE'S TOP IS BROKEN OFF AND NOT ATTACHED. TEAM HAS DISCOVERED 6 EFFECTED CARTRIDGES IN THE BOX. LOT 000X150207, EXPIRE 6/18/2027. PT CODE: 4582. DEVICE CODES: 1069, 2588. REFERENCE REPORTS: MW5186149, MW5186150, MW5186151, MW5186152, MW5186154.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808348 IDNOW STREP A KITS REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM OOI ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 000X150207

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown