BEUDAMED
    FDA Recall Terminated

    Calcium (CPC) R1 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R1 Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC402-R1. Calcium CPC Hitachi Reagent Set for repackaging, Catalog # 3-HC902-R1. The product is used for the quantitative determination of calcium in serum on Hitachi analyzers.

    Recall: Z-1042-2010 · Initiated November 10, 2009

    Recall

    Recall Number
    Z-1042-2010
    Event Number
    53784
    Firm
    Pointe Scientific, Inc.
    FEI Number
    1827821
    Product Code
    CIC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 10, 2009
    Posted
    March 10, 2010
    Terminated
    December 10, 2010
    Address
    5449 Research Dr, Canton, MI, 48188

    Description

    Calcium (CPC) R1 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R1 Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC402-R1. Calcium CPC Hitachi Reagent Set for repackaging, Catalog # 3-HC902-R1. The product is used for the quantitative determination of calcium in serum on Hitachi analyzers.

    Reason

    Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.

    Action

    Consignees were notified by "Urgent: Medical Device Recall" letter dated November 11, 2009 and instructed to conduct a recall to the retail level, that users should dispose of the product immediately, and that a business reply card should be returned to account for products. If you have any questions, please call Pointe Scientific, Inc. Technical Support Department at 1-800-757-5313 or 1-734-487-8300.

    Distribution

    Worldwide Distribution (United States, Chile, India, Republic of Yemen and Trinidad).

    Quantity

    6 sets and 21 L