BEUDAMED
    FDA Adverse Event Other Summary report: N

    PARAFFIN PRETREATMENT KIT II AND KIT III

    MDR report key: 1559647 · Received December 10, 2009

    Report

    Report Number
    3005248192-2009-00005
    Event Type
    Other
    Date Received
    December 10, 2009
    Date of Event
    November 13, 2009
    Report Date
    December 10, 2009
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    KEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FOR LOT # 7J02-03. A FIELD CORRECTION IN THE FORM OF A CUSTOMER LETTER AND A TELEPHONE PROTOCOL WILL BE DEVELOPED TO INFORM THE CUSTOMERS OF THIS LABELING ISSUE FOR THE PARAFFIN PRETREATMENT REAGENT KIT II AND PARAFFIN PRETREATMENT KIT III. NO COMPLAINTS FROM CUSTOMERS HAVE BEEN REPORTED DUE TO THIS ISSUE. THE DATE OF EVENT IS WHEN ABBOTT MOLECULAR DECIDED TO TAKE A FIELD ACTION AND INFORM CUSTOMERS OF THIS LABELING ISSUE.

    Description of Event or Problem · 1

    AN INTERNAL INVESTIGATION HAS IDENTIFIED THAT THE PARAFFIN PRETREATMENT REAGENT KIT II AND PARAFFIN PRETREATMENT REAGENT III DID NOT HAVE ANY HAZARD OR MSDS INFORMATION INCLUDED IN THEIR LABELING. APPROPRIATE SYMBOLOGY FOR HAZARDOUS AND CORROSIVE MATERIAL HAS NOT BEEN INCLUDED ON THE VIAL LABEL, KIT LABEL AND PACKAGE INSERT. AN ABBOTT MOLECULAR EMPLOYEE DISCOVERED THIS LABELING ISSUE. THE PARAFFIN PRETREATMENT REAGENT KIT II WERE 420563, 420008, 418294. THE PARAFFIN PRETREATMENT REAGENT KIT III LOTS WERE 420063 AND 418669.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARAFFIN PRETREATMENT KIT II AND KIT III NONE KEO ABBOTT MOLECULAR, INC. 7J02-02 420563

    Patients

    Seq Age Sex Outcome Treatment
    1