Microgenics Corporation: Medical Device Recall in 2014 - (Recall #: Z-1930-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

MAS Omni Immune PRO Controls

Product Classification:

Class III

Date Initiated: December 2, 2013

Date Posted: July 2, 2014

Recall Number: Z-1930-2014

Event ID: 67011

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.

Status: Terminated

Product Quantity: 1393

Code Information:

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated