BEUDAMED
    FDA Recall Terminated

    Fisher Healthcare Sure-Vue Serum/Urine hCG-STAT; in vitro diagnostic test; Catalog Number: FHC-A202; Product Codes: FHC-A202-KFI3O & FHC-A202-KFI5O; Inverness Medical Professional Diagnostics, San Diego, CA 92121.

    Recall: Z-1118-2008 · Initiated October 1, 2007

    Recall

    Recall Number
    Z-1118-2008
    Event Number
    45911
    Firm
    Innovacon Inc
    FEI Number
    3005689981
    Product Code
    JHI
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    October 1, 2007
    Posted
    May 6, 2008
    Terminated
    August 12, 2011
    Address
    4106 Sorrento Valley Blvd, San Diego, CA, 92121-1407

    Description

    Fisher Healthcare Sure-Vue Serum/Urine hCG-STAT; in vitro diagnostic test; Catalog Number: FHC-A202; Product Codes: FHC-A202-KFI3O & FHC-A202-KFI5O; Inverness Medical Professional Diagnostics, San Diego, CA 92121.

    Reason

    Incorrect results: The Sure-Vue Serum/Urine hCG-STAT test, when interpreted at extended read times, may exhibit sensitivity to patient samples containing hCG at levels well below the cut-off, potentially resulting in a false positive interpretation by the user.

    Action

    Inverness Medical sent an Urgent Medical Device Alert letter, dated October 1, 2007, to all Innovacon customers for the product via US Postal Service return receipt requested. The field correction notice removed the extended read time of 10 minutes. Customers were instructed to note that although the package insert currently allows interpretation up to 10 minutes, do not read at times greater than 3 minutes for urine and 5 minutes for serum.

    Distribution

    Nationwide

    Quantity

    1,825,480 units