MAS Omni Immune PRO Controls
Reported: July 2, 2014 Initiated: December 2, 2013 #Z-1930-2014
Product Description
MAS Omni Immune PRO 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.
Details
- Recalling Firm
- Microgenics Corporation
- Units Affected
- 1393
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Australia, China, Germany, Hong Kong and Malaysia.
- Location
- Fremont, CA
Frequently Asked Questions
What product was recalled? ▼
MAS Omni Immune PRO Controls. Recalled by Microgenics Corporation. Units affected: 1393.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 2, 2014. Severity: Low. Recall number: Z-1930-2014.
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