BEUDAMED
    FDA Recall Terminated

    Super Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP, REF/Cat. No. QP300-XAK, Kit containing reagent vials, Bio-Genex, San Ramon, CA.

    Recall: Z-0217-2007 · Initiated October 3, 2006

    Recall

    Recall Number
    Z-0217-2007
    Event Number
    36514
    Firm
    Biogenex Laboratories
    FEI Number
    2936532
    Product Code
    NJT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 3, 2006
    Posted
    December 8, 2006
    Terminated
    December 4, 2007
    Address
    4600 Norris Canyon Road, San Ramon, CA, 94583-1320

    Description

    Super Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP, REF/Cat. No. QP300-XAK, Kit containing reagent vials, Bio-Genex, San Ramon, CA.

    Reason

    Mislabeling: The product's "contents section " labeling (outer box) is mislabeled incorrectly printed as '1 x 100 mL Alk Phos Label' which should read '1 x 100 mL HRP Label'. A second, smaller label, incorrectly reads "RTU MultiLink HPR/AEC" which should be labeled as "RTU MultiLink HPR". The reagent vials in the box are correctly labeled.

    Action

    The firms provided written notificaiton letter on approximately 10/03/06, which includes a ''reply back form'' which the firm has requested to be sent back to them. The firm has asked distributors to inform their accounts of the correction, in the event that the product has been shipped out to customers.

    Distribution

    Worldwide-USA (including VA Medical Center) and Greece, Jordan, France, India, Taiwan, United Kingdom, Turkey, and Italy

    Quantity

    158 units