Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO — Class III medical device recall Z-0379-2013
Terminated recall by Microgenics Corporation, reported 2012-11-28, distributed nationwide. In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are
| Recall number | Z-0379-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microgenics Corporation, Fremont, CA, United States |
| Recall initiated | 2012-08-20 |
| Classified | 2012-11-19 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2013-03-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DE |
| Reason classes | specification failure |
| Lot numbers | OIM-101, OIM-202, OIM-303, OIM14031, OIM14032, OIM14033, OIM1403SMAS |
Product
Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance or reagent and instrument. .
Reason for recall
In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability.
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-0379-2013. 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.