Home / Recalls / Microgenics Corporation / Z-1930-2014

Z-1930-2014 Class III Terminated

Recalled by Microgenics Corporation — Fremont, CA

Recall Details

Product Type
Devices
Report Date
July 2, 2014
Initiation Date
December 2, 2013
Termination Date
July 8, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1393

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.

Distribution Pattern

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

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.

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