BEUDAMED
    FDA Recall Terminated

    Pointe Scientific Creatinine Reagent R2, Pointe Scientific, Inc., Canton, MI; Catalog 3-C7539-L, 7-C7539-R2-30, 7-C7539-R2-125, 7-C7539-R2-250, 8-C7539-R2-30, 8-C7539-R2-125 and 8-7539-R2-250. For the quantitative determination of creatinine in serum. For in-vitro diagnostic use only.

    Recall: Z-1036-2010 · Initiated December 1, 2009

    Recall

    Recall Number
    Z-1036-2010
    Event Number
    54094
    Firm
    Pointe Scientific, Inc.
    FEI Number
    1827821
    Product Code
    CGX
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    December 1, 2009
    Posted
    March 9, 2010
    Terminated
    October 15, 2010
    Address
    5449 Research Dr, Canton, MI, 48188

    Description

    Pointe Scientific Creatinine Reagent R2, Pointe Scientific, Inc., Canton, MI; Catalog 3-C7539-L, 7-C7539-R2-30, 7-C7539-R2-125, 7-C7539-R2-250, 8-C7539-R2-30, 8-C7539-R2-125 and 8-7539-R2-250. For the quantitative determination of creatinine in serum. For in-vitro diagnostic use only.

    Reason

    An additional 10% picric acid was added to the R2 component during production.

    Action

    Consignees were notified by An Urgent: Medical Device Recall letter, dated 12/1/09, that identified the affected product. Customers were asked to immediately examine their inventory for the affected product and to notify any customers that the product may have been further distributed to by giving them a copy of the recall notice. Customers are to dispose of the affected product immediately. Questions should be directed to the Technical Support Department at (800)757-5313 or (734)487-8300. There is also a Recall Response form attached with this notice.

    Distribution

    Worldwide Distribution -- USA, Bolivia, Greece, Guyana, India, Indonesia, Israel, Kenya, Korea, Malaysia, Mexico, Pakistan, Philippines, Russia, Serbia, Sri Lanka, Tanzania, Trinidad and Ukraine.

    Quantity

    625 vials