BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIASTAT ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL

    MDR report key: 6600314 · Received May 31, 2017

    Report

    Report Number
    9616003-2017-00002
    Event Type
    Malfunction
    Date Received
    May 31, 2017
    Date of Event
    April 28, 2017
    Report Date
    May 30, 2017
    Manufacturer
    EURO DIAGNOSTICA AB
    Product Code
    LKJ
    UDI-DI
    07340058410486
    PMA / PMN Number
    K932876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER SHIPMENT, STABILITY TEST PERFORMED ON THE KIT LOT HAS SHOWN THAT THE KIT FUNCTIONS AS EXPECTED AND HENCE THE KIT CAN BE USED THROUGH-OUT THE ORIGINAL SHELF-LIFE. THEREFORE, THE MATTER IS DEEMED TO NOT AFFECT PATIENT SAFETY. SINCE THE KIT LOT WAS ALREADY SHIPPED WITH THE SHORTER SHELF-LIFE, THIS EXPIRY DATE MUST BE ADHERED TO, BUT SINCE THE NEW DATE IS NOT STATED ON THE ALERT STICKER AND THE ORIGINAL KIT BOX LABEL REMAINED ON THE KIT BOX STATING THE ORIGINAL EXPIRATION DATE, IT COULD BE CONSIDERED MISBRANDING WHICH IS THE REASON FOR THE RECALL. THE RECALL DECISION WAS TAKEN BY THE QUALITY REVIEW BOARD 2017-05-22. ALL AFFECTED COUNTRIES REGULATORY AUTHORITIES, AS WELL AS ALL AFFECTED EURO DIAGNOSTICA CUSTOMERS, HAVE BEEN NOTIFIED OF THE RECALL. A FIELD SAFETY NOTICE WAS SENT OUT. THE EXTENT OF THE PROBLEM IS PRESENTLY DEEMED TO BE ONLY FANA200 TS 3577.

    Description of Event or Problem · 1

    FANA200 KIT LOT TS 3577 WAS RE-WORKED DUE TO SHORTENED SHELF-LIFE. THE ALERT STICKER ON THE KIT BOX OF THE LOT INFORMED CUSTOMERS THAT THE SHELF-LIFE HAD BEEN SHORTENED AND REFERENCED A LETTER SENT TO CUSTOMERS FOR MORE INFORMATION, WHERE THE NEW EXPIRATION DATE WAS STATED. THE ORIGINAL KIT BOX LABEL REMAINED ON THE KIT BOX STATING THE ORIGINAL EXPIRATION DATE. THE ALERT STICKER DID NOT HAVE THE NEW EXPIRATION DATE STATED ON IT. IT HAS NOW COME TO EURO DIAGNOSTICA'S ATTENTION THAT IT WOULD HAVE BEEN PREFERABLE TO HAVE HAD THE NEW EXPIRATION DATE STATED ON THE ALERT STICKER. A RECALL OF THE LOT HAS THEREFORE BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381238 DIASTAT ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL ANA LKJ EURO DIAGNOSTICA AB TS 3577 07340058410486

    Patients

    Seq Age Sex Outcome Treatment
    1