MAS Omni Immune Controls
FDA device recall Z-1929-2014 · posted 2014-06-26 · Terminated
Recall details
- Recalling firm
- Microgenics Corporation
- Reason for recall
- The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; however the package insert was not updated to reflect the change.
- Action taken
- Urgent Medical Device Correction letters were sent on December 2, 2013 to all affected customers and distributors via trackable mail.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- JJY
- Quantity affected
- 3185
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Australia, China, Germany, Hong Kong and Malaysia.
- Date initiated
- 2013-12-02
- Date posted
- 2014-06-26
- Date terminated
- 2014-07-08
- Location
- Fremont, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO (K110616) | Microgenics Corp. | 2011-06-29 |