MAS Omni Immune PRO Controls
- Company
- Microgenics Corporation
- Recall Initiated
- December 2, 2013
- Posted
- June 26, 2014
- Terminated
- July 8, 2014
- Recall Number
- Z-1930-2014
- Quantity
- 1393
- 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 OPR0-101 OPR015101 OPR0-202 OPR015102 OPR0-303 OPR015103 OPRO-SP OPR01510S All lots have an expiration date of 10/31/2015.
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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