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Lower risk Medical device recall · FDA · Published August 17, 2026

MAS Omni IMMUNE PRO Liquid Assayed Control Recall: Low PTH Recovery Risk

Microgenics recalls MAS Omni IMMUNE PRO Liquid Assayed Control (Lot OPRO29061A) due to low Parathyroid Hormone recovery risks in test results. Affected units sold worldwide in 2026.

🇺🇸 FDA recall #Z-0159-2027Medical deviceMicrogenics ›
✎ GovInfoNow plain-language explainer

What happened, in plain English

Microgenics recalls a specific blood test control product because inconsistent results may delay accurate Parathyroid Hormone measurements. This could affect medical testing accuracy for patients using the product. Read more at govinfonow.com/recall/1764890-microgenics-corporation-recalls-mas-omni-immune-pro-liquid-assayed-integrated.

Source Summary by GovInfoNow · govinfonow.com/recall/1764890-microgenics-corporation-recalls-mas-omni-immune-pro-liquid-assayed-integrated · Published October 27, 2026 · Updated October 27, 2026 · FDA enforcement record: FDA #Z-0159-2027

Cite this page

“MAS Omni IMMUNE PRO Liquid Assayed Control Recall: Low PTH Recovery Risk.” GovInfoNow, updated October 27, 2026. https://govinfonow.com/recall/1764890-microgenics-corporation-recalls-mas-omni-immune-pro-liquid-assayed-integrated. Based on FDA recall #Z-0159-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0159-2027%22&limit=1).

Why it’s dangerous

The control product has inconsistent results between vials, leading to low Parathyroid Hormone recovery. This may cause delays in reporting accurate patient test results.

Who’s affected

Patients using this blood test control product for medical testing may experience delayed Parathyroid Hormone results. Healthcare providers using the product in labs are most at risk.

How to tell if you have this one

Check for the product name 'MAS Omni IMMUNE PRO Liquid Assayed Control' with lot number OPRO29061A. The expiration date is June 30, 2029.

  • Brand
    Microgenics
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the lot number on the product label is OPRO29061A.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 11 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “Worldwide - US Nationwide distribution in the states of UT, MI, OK, NY, TX, CA, LA, SC, OH, MO, OR and the countries of KOR, BGD, THA, ZAF, DEU, VNM, BRA, NZL.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Louisiana, Michigan, Missouri, New York, Ohio, Oklahoma, Oregon, South Carolina, Texas, Utah.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Aug 17, 202612. FDA classified it Class II: Oct 15, 202623. Published in FDA’s Enforcement Report: Oct 21, 202634. Added to GovInfoNow: Oct 27, 202642026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0159-2027 (August 17, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0159-2027 to see it in context.
  • Plain-language summary written by qwen3:4b on October 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA