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Recall Observatory FDA recall evidence

Device product

MAS Omni Immune Controls

Z-1929-2014

December 02, 2013

Class III

Product summary

Firm
Microgenics Corporation
Event
Event 67011
Status
Terminated
Classification
Class III
Quantity
3185
Official record key
device-enforcement:Z-1929-2014

Official wording

Reason: 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.

Code information: 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.

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Australia, China, Germany, Hong Kong and Malaysia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.