ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8013, Provider Pack: 10 test (with lancet), Product is
FDA device recall Z-0287-2012 · posted 2011-11-25 · Terminated
Recall details
- Recalling firm
- Immunetech Inc
- 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.
- Action taken
- 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.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 930
- Distribution
- Worldwide distribution.
- Date initiated
- 2011-11-04
- Date posted
- 2011-11-25
- Date terminated
- 2012-06-14
- Location
- Foster City, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO MYALLERGY TEST (K061979) | Immunetech Corporation | 2006-09-22 |
| MY ALLERGY TEST (K021698) | Immunetech Corporation | 2002-09-19 |