BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOND AND NOVOCASTRA

    MDR report key: 2455347 · Received February 6, 2012

    Report

    Report Number
    3004859032-2012-00001
    Event Type
    Malfunction
    Date Received
    February 6, 2012
    Date of Event
    December 5, 2011
    Report Date
    December 6, 2011
    Manufacturer
    LEICA BIOSYSTEMS NEWCASTLE LTD
    Product Code
    NJT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL INVESTIGATION REVEALED THAT CD2 CELLS WERE GROWN AS CD7 AND LIKEWISE, CD7 CELLS AS CD2. BOTH CD2 AND CD7 ARE MEMBRANE MARKERS OF MOST T-CELLS AND NK-CELLS AND ARE USED AS PART OF A PANEL ALONGSIDE OTHER T-CELL MARKERS. SINCE CD2 AND CD7 EXPRESSION MAY VARY BETWEEN REACTIVE T-CELL PROLIFERATIONS AND T-CELL LYMPHOMAS, THE DECISION WAS MADE TO CONDUCT A RECALL. PA0271 LOTS 08173, 11855, 14784, PA0266 LOTS 10604, 13566, NCL-CD7-580 LOTS L158018, L158019, L158020. OUR COURSE OF ACTION IS TO RELEASE A FIELD CORRECTION LETTER TO INFORM ALL CUSTOMERS OF THE AFFECTED LOTS OF THIS ISSUE AND REQUEST ANY UNUSED PRODUCT TO BE RETURNED. CLINICIANS ARE ALSO ADVISED THAT THEY MAY WISH TO REVIEW RESULTS OBTAINED FROM THESE LOTS. CORRECTIVE ACTIONS INCLUDE REVIEW OF PROCESSES IN TISSUE CULTURE PRODUCTION AND IMPLEMENT TIGHTENED LINE-CLEARANCE PROCEDURE TO AVOID FURTHER MIX-UPS.

    Description of Event or Problem · 1

    (B)(4) WAS RECEIVED FROM A CUSTOMER IN (B)(6) REGARDING BOND RTU CD7 ((B)(4)). IT WAS NOTED THAT STAINING WITH BOND RTU CD7 WAS GIVING A DIFFERENT STAINING PATTERN TO THE CONCENTRATE VERSION I.E. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOND AND NOVOCASTRA IMMUNOHISTOCHEMISTRY REAGEANT NJT LEICA BIOSYSTEMS NEWCASTLE LTD PA0271,PA0266, CD7 VARIOUS

    Patients

    Seq Age Sex Outcome Treatment
    1