BEUDAMED
    FDA Recall Terminated

    Pointe Scientific, Inc. Iron Color Reagent, Pointe Scientific, Inc., Canton, MI., Catalog #s: 7-I7504-COL-15, 7-I7504-COL-5, 7-I7504-COL-60, 8-I7504-COL-15, 8-I7504-COL-60 and 3-I7504-COL. Clinical chemistry reagent for the quantitative determination of iron in serum.

    Recall: Z-0905-2010 · Initiated November 16, 2009

    Recall

    Recall Number
    Z-0905-2010
    Event Number
    53872
    Firm
    Pointe Scientific, Inc.
    FEI Number
    1827821
    Product Code
    JIY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 16, 2009
    Posted
    March 2, 2010
    Terminated
    June 6, 2011
    Address
    5449 Research Dr, Canton, MI, 48188

    Description

    Pointe Scientific, Inc. Iron Color Reagent, Pointe Scientific, Inc., Canton, MI., Catalog #s: 7-I7504-COL-15, 7-I7504-COL-5, 7-I7504-COL-60, 8-I7504-COL-15, 8-I7504-COL-60 and 3-I7504-COL. Clinical chemistry reagent for the quantitative determination of iron in serum.

    Reason

    Turbidity formation could occur, resulting in invalid test results being reported out.

    Action

    Consignees were notified by recall letter dated 11/16/09 and instructed to discard any remaining product. Please call 1-800-757-5313 if you have questions.

    Distribution

    Nationwide, Australia, Austria, Bolivia, Canada, Cyprus, Egypt, Ghana, Greece, Guyana, India, Indonesia, Israel, Jordan, Kenya, Korea, Lebanon, Macedonia, Malaysia, Mexico, Nicaragua, Nigeria, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Trinidad, Turkey, Ukraine and Venezuela.

    Quantity

    168 sets plus 154 L