FDAFDA · Food and drugs·Recall number Z-1929-2014
MAS Omni Immune Controls
Published July 2, 2014 · Recall initiated: December 2, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Microgenics Corporation
- Distributor
- Worldwide Distribution-USA (nationwide) and the countries of Australia, China, Germany, Hong Kong and Malaysia.
- Lot
- 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.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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