FDA Device recall Z-1930-2014
MAS Omni Immune PRO Controls
- FDA Device
- Class III
- terminated
- Published 2014-07-02
On 2014-07-02 the FDA classified a Class III recall of MAS Omni Immune PRO Controls by Microgenics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1930-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-12-02 |
| Published | 2014-07-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Microgenics |
| Distribution | US |
Product
MAS Omni Immune PRO Controls
Reason
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.
Identifiers
| code_info | Part Number Lot number OPR0-101 OPR015101 OPR0-202 OPR015102 OPR0-303 OPR0…Part Number Lot number OPR0-101 OPR015101 OPR0-202 OPR015102 OPR0-303 OPR015103 OPRO-SP OPR01510S All lots have an expiration date of 10/31/2015. |
|---|
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-1930-2014%22
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