Z-1930-2014Class III

MAS Omni Immune PRO Controls

Name: Z-1930-2014 MAS Omni Immune PRO Controls
Creator: Microgenics Corporation
Published: 2013-12-02
License: https://open.fda.gov/license/

Microgenics Corporation / initiated 2013-12-02 / Terminated / root cause: labeling and UDI

FDA source

Microgenics Corporation began a recall of MAS Omni Immune PRO Controls on 2013-12-02. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1930-2014
Classification: Class III
Status: Terminated
Initiated: 2013-12-02
Posted: 2014-06-26
Terminated: 2014-07-08
Recalling firm: Microgenics Corporation
Product: MAS Omni Immune PRO Controls
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Urgent Medical Device Correction letters were sent on December 2, 2013 to all affected customers and distributors via trackable mail.
Quantity in commerce: 1393
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Australia, China, Germany, Hong Kong and Malaysia.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1930-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1929-2014	Class III	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-26
Z-1930-2014	Class III	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-26

Product code JJY

K110616Class IThermo Scientific Mas Omni-Immune, Mas Omni Immune ProMicrogenics Corp. / cleared 2011-06-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)