Device product
MAS Omni Immune PRO Controls
Z-1930-2014
Product summary
- Event
- Event 67011
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1393
- Official record key
device-enforcement:Z-1930-2014
Official wording
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.
Code information: 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.
Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Australia, China, Germany, Hong Kong and Malaysia.
Derived failure modes
-
Unknown
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.