BEUDAMED
    FDA Recall Terminated

    Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit, Fisher Diagnostics catalog number 100250, containing reagents for 30 determinations.

    Recall: Z-1496-04 · Initiated September 3, 2004

    Recall

    Recall Number
    Z-1496-04
    Event Number
    30004
    Firm
    Fisher Diagnostic, A Company of Fisher Scientific LLC
    FEI Number
    1181121
    Product Code
    GHM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 3, 2004
    Posted
    September 30, 2004
    Terminated
    May 3, 2005
    Address
    8365 Valley Pike, Middletown, VA, 22645-1905

    Description

    Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit, Fisher Diagnostics catalog number 100250, containing reagents for 30 determinations.

    Reason

    Defective reaction vials from an in vitro diagnostic test kit may cause positive patient samples to be interpreted as false negatives.

    Action

    The firm ceased distribution on 8/24/04 and initiated recall by certified letter dated 9/3/04, which was flagged as 'customer recall notification'. The notice advised of the defective vials and requested users to return response form with the numbers of kits to be returned for replacement.

    Distribution

    Product was distributed through the manufacturer''s affiliate distribution company to 228 end users nationwide.

    Quantity

    604 kits