BEUDAMED
    FDA Recall Terminated

    RESOLVE Hemoglobin Test Kits packed and distributed under the Perkin Elmer Life and Analytical Sciences label, Kit Codes: FR-9120 - 120 tests per kit; FR-9400 - 360 tests per kit; and FR-9360 - 3600 tests per kit.

    Recall: Z-0047-05 · Initiated September 14, 2004

    Recall

    Recall Number
    Z-0047-05
    Event Number
    30017
    Firm
    PerkinElmer LAS Inc
    FEI Number
    1522510
    Product Code
    GKA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 14, 2004
    Posted
    October 28, 2004
    Terminated
    October 29, 2008
    Address
    3985 Eastern Rd, Norton, OH, 44203-6215

    Description

    RESOLVE Hemoglobin Test Kits packed and distributed under the Perkin Elmer Life and Analytical Sciences label, Kit Codes: FR-9120 - 120 tests per kit; FR-9400 - 360 tests per kit; and FR-9360 - 3600 tests per kit.

    Reason

    The product insert for the test kits is incorrect with regard to the acceptable storage temperature for the Agarose IEF gel component. The kit and IEF gel labels indicate the correct storage temperature of 2-8 degrees C. The product insert incorrectly indicates that the product may be stored at 2-30 degrees C.

    Action

    The firm contacted their consignees by letter dated 9/14/04.

    Distribution

    Nationwide (The product was distributed to firms located in AR, AZ, CA, CO,FL, GA, HI, IA, IL, IN, KS, KY,LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV )and worldwide (to 12 foreign accounts).

    Quantity

    All lots of test kits manufactured by the firm which have an active shelf life are subject to recall.