BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW STREP PNEUMONIAE 22T (LFR)

    MDR report key: 24874508 · Received April 14, 2026

    Report

    Report Number
    1221359-2026-00050
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Date of Event
    March 19, 2026
    Report Date
    April 14, 2026
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    GTZ
    UDI-DI
    10811877011085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 710-100 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 710-000. THE REMAINDER OF THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED PENDING COMPLETION, OR UPON RECEIPT OF NEW INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THREE (3) FALSE NEGATIVE RESULTS WITH THE BINAXNOW STREP PNEUMONIAE 22T ASSAY PERFORMED ON THREE (3) PATIENTS BETWEEN (B)(6) 2026 AND (B)(6) 2026 WITH AN UNKNOWN SAMPLE TYPE. THIS REPORT IS FOR PATIENT ONE (1) OF THREE (3). THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW STREP PNEUMONIAE 22T ASSAY PERFORMED ON (B)(6) WITH AN UNKNOWN SAMPLE TYPE. CONFIRMATORY TESTING RESULTS WERE NOT PROVIDED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION, INCLUDING PATIENT INFORMATION, TREATMENT, OR OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935883 BINAXNOW STREP PNEUMONIAE 22T (LFR) ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP. GTZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 0000982302 10811877011085

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown