Class 2 Device Recall MyAllergyTest, Specimen Collection Kit

• Date Initiated by Firm: November 04, 2011
• Date Posted: November 25, 2011
• Recall Status: Terminated on June 14, 2012
• Recall Number: Z-0286-2012
• 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. 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.
• Code Information: Lot Numbers: F0060, F0083, F0094, F0095, F0096, G0005, G0022, G0023, G0026, G0028, G0043, G0044, G0048, G0050, G0056, G0058, H0005, H0007, H0009, H0023, H0047, H0049, H0052, I0002, I0104, I0112, I0115
• 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: 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: 1930
• 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