BEUDAMED
    FDA Recall Terminated

    ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8001; Individually Packaged Kit, Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the non-sterile alcohol prep pads are manufactured by H & P Industries, Inc., Triad Group, Hartland, WI The MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing.

    Recall: Z-0286-2012 · Initiated November 4, 2011

    Recall

    Recall Number
    Z-0286-2012
    Event Number
    60355
    Firm
    Immunetech Inc
    FEI Number
    3004091547
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    November 4, 2011
    Posted
    November 25, 2011
    Terminated
    June 14, 2012
    Address
    373 Vintage Park Dr, Ste A, Foster City, CA, 94404-1139

    Description

    ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8001; Individually Packaged Kit, Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the non-sterile alcohol prep pads are manufactured by H & P Industries, Inc., Triad Group, Hartland, WI The MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing.

    Reason

    ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group, Hartland, WI due to Bacillus cereus, microbial contamination.

    Action

    The firm, IMMUNETECH, sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated November 4, 2011, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect their inventory and quarantine all affected kits; if they have further distributed the affected kits, contact Immunetech to accurately identify and immediately notify their customers and facilitate the return and exchange of all remaining kits. If you have any questions, call (650) 312-1066, Monday-Friday, 9:00am -5:00pm (pacific) or email: [email protected].

    Distribution

    Worldwide distribution.

    Quantity

    1930