BEUDAMED
    FDA Enforcement Class III Terminated

    Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of pregnancy. This test is for professional use.

    Recall: Z-1344-2013 · Reported May 29, 2013

    Enforcement

    Recall Number
    Z-1344-2013
    Event ID
    49026
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alere San Diego, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 29, 2013
    Initiation Date
    January 21, 2013
    Classification Date
    May 21, 2013
    Termination Date
    August 28, 2013
    Address
    9975 Summers Ridge Rd, N/A, San Diego, CA, 92121-2997, United States

    Description

    Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of pregnancy. This test is for professional use.

    Reason

    Alere San Diego Inc. is recalling the Cardinal Health hCG Cassette Rapid Test because some of them were incorrectly packaged into Cardinal Health hCG Combo Rapid test kit boxes. The kit box incorrectly indicates the product may be used for both urine and serum sample types.

    Code Info

    Lot: hCG2080330

    Distribution

    Nationwide distribution: USA including states of: AL, AK, AR, AZ, CA, CO, CT, DE, HI, IA, ID, IL, IN, FL, GA, KY, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, UT, TN, TX, VA, WA, WI, WV AND WY.

    Quantity

    2,167 kits