Recall of Device Recall MyAllergyTest, Specimen Collection Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Immunetech Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60355
  • Event Risk Class
    Class 2
  • Event Number
    Z-0291-2012
  • Event Initiated Date
    2011-11-04
  • Event Date Posted
    2011-11-25
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2012-06-14
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tubes, vials, systems, serum separators, blood collection - Product Code JKA
  • 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: customersupport@immunetech.com.

Device

  • Model / Serial
    Lot Numbers: G0013, G0053, G0057, H0030, H0048, H0058
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution.
  • Product Description
    ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. || 8024, Provider Pack: 5 test, || 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.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Immunetech Inc, 373 Vintage Park Dr Ste A, Foster City CA 94404-1139
  • Manufacturer Parent Company (2017)
  • Source
    USFDA