Z-0379-2013Class III

Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control...

Name: Z-0379-2013 Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control...
Creator: Microgenics Corporation
Published: 2012-08-20
License: https://open.fda.gov/license/

Microgenics Corporation / initiated 2012-08-20 / Terminated / root cause: manufacturing process

FDA source

Microgenics Corporation began a recall of Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed control for monitoring... on 2012-08-20. FDA classified it as Class III and gives the reason as "In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0379-2013
Classification: Class III
Status: Terminated
Initiated: 2012-08-20
Posted: 2012-11-19
Terminated: 2013-03-04
Recalling firm: Microgenics Corporation
Product: Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance or reagent and instrument. .
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Microgenics Corporation sent a Recall Notification letter dated August 20, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed that immediate attention is required and identify the two affected constituents. The letter contains a list of the affected product with their catalog number, lot number and expiration date and request that the CK-MB and Insulin use be discontinued. The remaining components of the product may be used. Evaluate quality controls according to your laboratory procedures. Retain a copy of the letter for your laboratory records. If the product was forwarded to another laboratory, provide them with a copy of the letter. Complete the attached Recall Response form and return within 5 days. Questions may be directed to 1-800-232-3342.
Quantity in commerce: 2076 total in US , 596 total Foreign
Distribution: Worldwide Distribution--USA (nationwide) and the countries of Germany, Canada and Australia.
Product codes and lots: MAS Onmi IMMUNE: Catalog Number/lot number/ expiration date: OIM-101 - OIM14031 - 31 MAR 2014; OIM-202 - OIM14032 - 31 MAR 2014; OIM-303 - OIM14033 - 31 MAR 2014; OIM-SP - OIM1403S - 31 MAR 2014. MAS Omni IMMUNE PRO: OPRO-101 - OPRO14031 - 31 MAR 2014; OPRO-201 - OPRO14032 - 31 MAR 2014' OPRO-303 - OPRO14033 - 31 MAR 2014; OPRO-SP - OPRO1403S - 31 MAR 2014.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0379-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0379-2013	Class III	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19

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)