FDA recall, , Moderate risk
Microgenics MAS Omni IMMUNE PRO Immunoassay Controls
MAS Omni Immune Pro Liquid Assayed Integrated Immunoassay Control has vial-to-vial variability causing low PTH recovery, which may delay patient PTH results.
Summary by Recall Canary from the FDA notice
What happened
Microgenics Corporation recalled MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101, and MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Control, Sample Pack, REF: OPRO-SP, because vial-to-vial variability results in low Parathyroid Hormone (PTH) recovery, which may lead to a delay in reporting patient PTH results.
The recall began on August 17, 2026, and was added to the FDA's Enforcement Report on October 15, 2026. Distribution included nationwide in the US and other countries.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the reference number. Check the FDA notice for any lot or serial number limits.
MAS Omni Immune Pro Liquid Assayed Integrated Immunoassay Control, Level 1
- Reference number
- OPRO-101
MAS Omni Immunetm Pro Liquid Assayed Integrated Immunoassay Control, Sample Pack
- Reference number
- OPRO-SP
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Utah, Michigan, Oklahoma, New York, Texas, California, Louisiana, South Carolina, Ohio, Missouri, Oregon and the countries of KOR, BGD, THA, ZAF, DEU, VNM, BRA, NZL.
- Company
- Microgenics Corporation
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99736
- Recall number
- Z-0159-2027
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
