Z-0288-2012

ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8014, Provider Pack: 10 test (without...

Name: Z-0288-2012 ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8014, Provider Pack: 10 test (without...
Creator: Immunetech Inc
Published: 2011-11-04
License: https://open.fda.gov/license/

Immunetech Corporation / initiated 2011-11-04 / Terminated / root cause: manufacturing process

FDA source

Immunetech Inc began a recall of ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8014, Provider Pack: 10 test (without lancet), Product is manufactured distributed by... on 2011-11-04. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0288-2012
Status: Terminated
Initiated: 2011-11-04
Posted: 2011-11-25
Terminated: 2012-06-14
Recalling firm: Immunetech Corporation
Product: ImmuneTech 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.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
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.
Root cause tag: manufacturing process
FDA root 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: [email protected].
Quantity in commerce: 310
Distribution: Worldwide distribution.
Product codes and lots: Lot Numbers: F0024, G0006, G0042, G0047, G0054, H0046

Product code JKA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)