BEUDAMED
    FDA Recall Terminated

    Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # H7511-60 and Catalog # H7511-SAM. HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; . (Clinical chemistry). For the quantitative determination of high density lipoprotein (HDL) in cholesterol in serum.

    Recall: Z-0859-2010 · Initiated November 10, 2009

    Recall

    Recall Number
    Z-0859-2010
    Event Number
    53810
    Firm
    Pointe Scientific, Inc.
    FEI Number
    1827821
    Product Code
    LBR
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 10, 2009
    Posted
    February 25, 2010
    Terminated
    February 11, 2011
    Address
    5449 Research Dr, Canton, MI, 48188

    Description

    Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # H7511-60 and Catalog # H7511-SAM. HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; . (Clinical chemistry). For the quantitative determination of high density lipoprotein (HDL) in cholesterol in serum.

    Reason

    The firm initiated the recall due to the presence of visible contamination of the product.

    Action

    Consignees were notified by an Urgent: Medical Device Recall letter (sent by email, fax or through the mails) dated 11/10/09. The letter identified the affected product and instructed customers to immediately examine their inventory. If the product was further distributed their customers should be identified and notified of the recall. Customers are instructed to dispose of any product in stock. Questions should be directed to the Technical Support Department at 800-757-5313 or 734-487-8300.

    Distribution

    Worldwide Distribution -- USA, Bolivia, Ghana, Jamaica, Kenya, Korea, Malaysia, Mexico, Nicaragua, Nigeria, Philippines, Poland, Sri Lanka and Trinidad.

    Quantity

    379 sets