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MAS Omni Immune PRO Controls

FDA Recall #Z-1930-2014 — Class III — December 2, 2013

Recall #Z-1930-2014 Date: December 2, 2013 Classification: Class III Status: Terminated

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.

Recalling Firm

Microgenics Corporation — Fremont, CA

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Devices

Product Quantity

1393

Distribution

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.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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