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U.S. Department of Health and Human Services

Class 2 Device Recall MyAllergyTest, Specimen Collection Kit

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  Class 2 Device Recall MyAllergyTest, Specimen Collection Kit see related information
Date Initiated by Firm November 04, 2011
Date Posted November 25, 2011
Recall Status1 Terminated 3 on June 14, 2012
Recall Number Z-0289-2012
Recall Event ID 60355
510(K)Number K021698  K061979  
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No.

8015, Screening Pack: 50 test (with lancet),

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.
Code Information Lot Number: G0040
Recalling Firm/
Manufacturer		 Immunetech Inc
373 Vintage Park Dr Ste A
Foster City CA 94404-1139
For Additional Information Contact Christopher Brown
650-312-1066
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Material/Component 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.
Quantity in Commerce 50
Distribution Worldwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JKA and Original Applicant = IMMUNETECH CORPORATION
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