BEUDAMED
    FDA Recall 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 · Initiated January 21, 2013

    Recall

    Recall Number
    Z-1344-2013
    Event Number
    49026
    Firm
    Alere San Diego, Inc.
    FEI Number
    1000125596
    Product Code
    JHI
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    January 21, 2013
    Posted
    May 21, 2013
    Terminated
    August 28, 2013
    Address
    9975 Summers Ridge Rd, San Diego, CA, 92121-2997

    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.

    Action

    The firm, Alere, sent an "URGENT MEDICAL DEVICE RECALL" letter dated January 21, 2013 to all their customers. The letter describes the product, problems identified and the actions to be taken. Customers are instructed to discontinue use and/or sale of the product; immediately discard all units of the the product in accordance with your local regulations; share this information with your laboratory staff and retain this letter for your records; if you have forwarded the product to another laboratory, provide a copy of this letter to them and include the name, address and a contact for the laboratory on the enclosed Customer Verification Form; complete and return the Customer Verification Form within 10 days via fax to: Technical Service at 858-805-8457 or e-mail to [email protected]. Customers with any questions are instructed to contact Alere Technical Services at (866) 216-0094 or by email at [email protected].

    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