FDAClass IIIJuly 2, 2014

MAS Omni Immune PRO Controls recall

MAS Omni Immune PRO Controls

Why was MAS Omni Immune PRO Controls 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models 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.

Product
MAS Omni Immune PRO Controls
Recalling firm
Microgenics Corporation
Quantity
1393
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Australia, China, Germany, Hong Kong and Malaysia.
Recall date
July 2, 2014
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls