Microgenics Recalls Thermo Scientific Omni IMMUNE Immunoassay Controls Due to Stability Issues
Microgenics is recalling Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO controls because internal testing showed reduced stability for CK-MS and Insulin.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The issue is a stability defect in a laboratory control product, not a direct patient safety hazard like a contaminated drug or device.
Plain-English summary
Microgenics Corporation is recalling Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Controls. These products are intended for use as assayed controls to monitor assay conditions in clinical laboratory determinations.
The recall was initiated after in-house testing confirmed that the CK-MS and Insulin components in both product lines are displaying reduced stability. The affected products were distributed worldwide, including the United States, Germany, Canada, and Australia. The specific catalog numbers, lot numbers, and expiration dates are listed in the structured product information.
Consumers and laboratories should stop using the affected products and contact Microgenics Corporation for further instructions on return or replacement.
The recalled product
- 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.…
- Manufacturer
- Microgenics Corporation
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- OIM-202 - OIM14032 - 31 MAR 2014
- OIM-303 - OIM14033 - 31 MAR 2014
- OPRO-201 - OPRO14032 - 31 MAR 2014' OPRO-303 - OPRO14033 - 31 MAR 2014
- OPRO-SP - OPRO1403S - 31 MAR 2014.
Distribution
Distributed nationwide across the United States.
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