MAS Omni Immune Controls
- Company
- Microgenics Corporation
- Recall Initiated
- December 2, 2013
- Posted
- June 26, 2014
- Terminated
- July 8, 2014
- Recall Number
- Z-1929-2014
- Quantity
- 3185
- Firm Location
- Fremont, CA
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
Worldwide Distribution-USA (nationwide) and the countries of Australia, China, Germany, Hong Kong and Malaysia.
Lot / Code Info
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.
Root Cause
Labeling Change Control
Action Taken
Urgent Medical Device Correction letters were sent on December 2, 2013 to all affected customers and distributors via trackable mail.
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