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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 Kitsee related information
Date Initiated by FirmNovember 04, 2011
Date PostedNovember 25, 2011
Recall Status1 Terminated 3 on June 14, 2012
Recall NumberZ-0288-2012
Recall Event ID 60355
510(K)NumberK021698 K061979 
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
ProductImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8014, Provider Pack: 10 test (without 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 Numbers: F0024, G0006, G0042, G0047, G0054, H0046
Recalling Firm/
Manufacturer
Immunetech Inc
373 Vintage Park Dr Ste A
Foster City CA 94404-1139
For Additional Information ContactChristopher 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
ActionThe 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 Commerce310
DistributionWorldwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JKA
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