BEUDAMED
    FDA Recall Terminated

    Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent in 50 ml, 120 ml, 2 L and 500 ml containers, sold by Pointe Scientific; Catalog nos. 7-HA716-R1-50-917, 7-A7516-R1-120, 7-A7516-R1-2L, 7-A7516-R1-500, 7-HA716-R1-500, 8-A7516-R1-120 and 8-A7516-R1-500. In vitro diagnostic.

    Recall: Z-1396-06 · Initiated June 9, 2006

    Recall

    Recall Number
    Z-1396-06
    Event Number
    35496
    Firm
    Pointe Scientific, Inc.
    FEI Number
    1827821
    Product Code
    CJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 9, 2006
    Posted
    August 10, 2006
    Terminated
    November 19, 2007
    Address
    5449 Research Dr, Canton, MI, 48188-2261

    Description

    Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent in 50 ml, 120 ml, 2 L and 500 ml containers, sold by Pointe Scientific; Catalog nos. 7-HA716-R1-50-917, 7-A7516-R1-120, 7-A7516-R1-2L, 7-A7516-R1-500, 7-HA716-R1-500, 8-A7516-R1-120 and 8-A7516-R1-500. In vitro diagnostic.

    Reason

    The reagent may be contaminated with microorganisms.

    Action

    Consignees were notified via recall letter dated 6/9/06 to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International consignees were notified via email.

    Distribution

    Worldwide, including USA, Bolivia, Cameroon, China, Cyprus, Egypt, Greece, India, Israel, Kenya, Korea, Lebanon, Malaysia, Mexico, Nepal, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Russia, Singapore, Thailand, Trinidad, Turkey, Ukraine United Arab Emirates and Venezuela.

    Quantity

    890 L total, all products