Microgenics Recalls MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control
Microgenics Corporation is recalling MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control products due to vial-to-vial variability that may delay patient PTH results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 Class II due to vial-to-vial variability causing low PTH recovery, which may delay patient results. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Microgenics Corporation is recalling MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1 (REF: OPRO-101) and MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Sample Pack (REF: OPRO-SP). The recall involves 1,366 units distributed nationwide in the United States and in several international countries.
The recall was initiated because vial-to-vial variability in the Level 1 control material results in low Parathyroid Hormone (PTH) recovery. This variability may lead to a delay in reporting patient PTH results. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and laboratories should stop using the affected products and contact Microgenics Corporation for further instructions on returns or replacements.
The recalled product
- Product
- MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Control, Sample Pack, REF: OPRO-SP
- Manufacturer
- Microgenics Corporation
- Hazard
- Affected units
- 1,366
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 (2)
- REF/UDI-DI/Lot(Expiration): OPRO-101/00884883005327/OPRO29061A(2029-06-30)
- OPRO-SP/00884883005358/OPRO2906SA(2029-06-30)
Distribution
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