FDAFDA · Food and drugs·Recall number Z-1930-2014
MAS Omni Immune PRO 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 OPR0-101 OPR015101 OPR0-202 OPR015102 OPR0-303 OPR015103 OPRO-SP OPR01510S All lots have an expiration date of 10/31/2015.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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