FDA Device recall Z-0379-2013
Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO
- FDA Device
- Class III
- terminated
- Published 2012-11-28
On 2012-11-28 the FDA classified a Class III recall of Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO by Microgenics, citing in house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0379-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-08-20 |
| Published | 2012-11-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Microgenics |
| Distribution | US |
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
In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability.
Identifiers
| code_info | MAS Onmi IMMUNE: Catalog Number/lot number/ expiration date: OIM-101 - OIM14031 - 31 MAR 2014; OIM-202 - OIM14032 -…MAS Onmi IMMUNE: Catalog Number/lot number/ expiration date: OIM-101 - OIM14031 - 31 MAR 2014; OIM-202 - OIM14032 - 31 MAR 2014; OIM-303 - OIM14033 - 31 MAR 2014; OIM-SP - OIM1403S - 31 MAR 2014. MAS Omni IMMUNE PRO: OPRO-101 - OPRO14031 - 31 MAR 2014; OPRO-201 - OPRO14032 - 31 MAR 2014' OPRO-303 - OPRO14033 - 31 MAR 2014; OPRO-SP - OPRO1403S - 31 MAR 2014. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0379-2013%22
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