BEUDAMED
    FDA Recall Terminated

    ImmunoCAP Allergen Ri206, Cockroach American, Periplaneta americana It is an analyte specific reagent and no intended use, however, it is typically used in vitro quantitive assay for the measurement of cockroach allergen IgE in human serum or plasma.

    Recall: Z-1055-2012 · Initiated January 3, 2012

    Recall

    Recall Number
    Z-1055-2012
    Event Number
    60513
    Firm
    Phadia US Inc
    FEI Number
    3004973408
    Product Code
    MVU
    Status
    Terminated
    Root Cause
    Release of Material/Component prior to receiving test results
    Initiated
    January 3, 2012
    Posted
    February 17, 2012
    Terminated
    February 4, 2013
    Address
    4169 Commercial Ave, Portage, MI, 49002-9701

    Description

    ImmunoCAP Allergen Ri206, Cockroach American, Periplaneta americana It is an analyte specific reagent and no intended use, however, it is typically used in vitro quantitive assay for the measurement of cockroach allergen IgE in human serum or plasma.

    Reason

    The firm found this lot of ImmunoCAP Allergen Ri206, American Cockroach does not contain sufficient levels of some cockroach allergens e.g. tropomyosin. Approximately 2% of the positive samples have a risk to fall below the Limit of Quantization (o .1 kUA/L).

    Action

    ThermoFisher sent an URGENT RECALL NOTIFICATION letter dated December 22, 2011, to all affected consignees. The letter identifed the product, the problem, and the action to be taken by the conignee. Consignees were recommended to cease testing on the affected lot of product and, if so desired, substitute with ImmunoCAP Allergen i6, German Cockroach, until ImmunoCAP Allergen Ri206 was in stock. For any questions regarding this notification, contact Technical Support at 800.346.4364, option 2.

    Distribution

    Nationwide to include: MN, VA, NC, MO, SC, TX, MA, MI, FL, IL, PA, MD, UT, CO, GA, CA,

    Quantity

    780; all sent to US, with 10 assays per sleeve