BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SERA PAPAIN

    MDR report key: 22327432 · Received June 25, 2025

    Report

    Report Number
    3011683976-2025-00006
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Report Date
    June 25, 2025
    Manufacturer
    ALBA BIOSCIENCE LIMITED (LTD.)
    Product Code
    KSK
    UDI-DI
    10758750030330
    PMA / PMN Number
    BK150246
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION STILL ON GOING AND AS SOON AS WILL BE COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED. ALBA BIOSICENCE REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    THE END USER REPORTS FALSE NEGATIVE RESULTS WITH ORTHO SERA PAPAIN PRODUCT FD317, LOT V278742, EXPIRY 30SEP25.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2290623 ORTHO SERA PAPAIN SOLUTION, STABILIZED ENZYME KSK ALBA BIOSCIENCE LIMITED (LTD.) V278742 10758750030330

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown