Z-1929-2014 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 2, 2014
- Initiation Date
- December 2, 2013
- Termination Date
- July 8, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3185
Product Description
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.
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Australia, China, Germany, Hong Kong and Malaysia.
Code Information
Part Number Lot number OIM-101 OIM15091 OIM-202 OIM15092 OIM-303 OIM15093 OIM-SP OIM1509S. All lots have an expiration date of 9/30/2015.