Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO Recalled by Microgenics Corporation Due to In house testing confirmed that CK-MS and Insulin...

Date: August 20, 2012
Company: Microgenics Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Microgenics Corporation directly.

Affected Products

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. .

Quantity: 2076 total in US , 596 total Foreign

Why Was This Recalled?

In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Microgenics Corporation

Microgenics Corporation has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report