BEUDAMED
    FDA Recall Terminated

    Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent; Catalog Nos. 7-A7516-R2-125, 7-A7516-R2-90 and 8-A7516-R2-30, In vitro diagnostic, 30 mL, 90 mL , 125 mL, and 400 mL containers, Sold by Pointe Scientific.

    Recall: Z-1359-2008 · Initiated February 7, 2008

    Recall

    Recall Number
    Z-1359-2008
    Event Number
    46783
    Firm
    Pointe Scientific, Inc.
    FEI Number
    1827821
    Product Code
    CJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 7, 2008
    Posted
    March 27, 2008
    Terminated
    June 12, 2009
    Address
    5449 Research Dr, Canton, MI, 48188

    Description

    Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent; Catalog Nos. 7-A7516-R2-125, 7-A7516-R2-90 and 8-A7516-R2-30, In vitro diagnostic, 30 mL, 90 mL , 125 mL, and 400 mL containers, Sold by Pointe Scientific.

    Reason

    May be contaminated with microorganisms.

    Action

    Consignees were notified via recall letter, Urgent Medical Device, dated 2/7/08, 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-USA, Canada, Chile, Cyprus, Ecuador, Greece, India, Italy, Jamaica, Korea, Nigeria, Pakistan, Philippines, Poland, Turkey and The West Indies.

    Quantity

    47