MAS Omni Immune Controls — Class III medical device recall Z-1929-2014
Terminated recall by Microgenics Corporation, reported 2014-07-02, distributed nationwide. The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; however the pac
| Recall number | Z-1929-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microgenics Corporation, Fremont, CA, United States |
| Recall initiated | 2013-12-02 |
| Classified | 2014-06-26 |
| Reported by FDA | 2014-07-02 |
| Terminated | 2014-07-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CN, DE, HK, MY |
| Quantity | 3,185 |
| Lot numbers | OIM-101, OIM-202, OIM-303, OIM15091, OIM15092, OIM15093, OIM1509S |
| Model numbers | OIM-101, OIM-202, OIM-303, OIM15091, OIM15092, OIM15093, OIM1509S |
| Expiration dates | 2015-09-30 |
Product
MAS Omni Immune Controls
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1929-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.