CLASS III Device recall · Reported 2 Jul 2014 · FDA Enforcement Report

MAS Omni Immune PRO Controls recalled by Microgenics

Microgenics is recalling MAS Omni Immune PRO Controls, distributed nationwide in the US. The recall was initiated on 2 Dec 2013 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesPart 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.

Quantity recalled1393

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1930-2014
FDA event ID: 67011
Recalling firm: Microgenics, Fremont, CA
Classification: Class III
Status: Terminated
Recall initiated: 2 Dec 2013
FDA classified: 26 Jun 2014
Reported: 2 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

2 Dec 2013	Recall initiated by company
26 Jun 2014	Classified by FDA	+206 days
2 Jul 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

MAS Omni Immune PRO Controls

Where it was distributed

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

Nationwide

Questions about this recall

Is MAS Omni Immune PRO Controls recalled?

Yes. Microgenics recalled MAS Omni Immune PRO Controls on 2 Dec 2013. The recall is Class III and its status is Terminated. Recall number Z-1930-2014.

Why was it recalled?

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.

Which lots are affected?

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.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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