Reported Oct 21, 2026 · Ongoing · Updated Oct 26, 2026

MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid…

Microgenics Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Microgenics Corporation · 46500 Kato Rd · Fremont, CA · 94538-7310

Is this the product you have?

  • MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1
  • REFOPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Control, Sample Pack
  • REFOPRO-SP
Lot codes and dates
  • REF/UDI-DI/Lot(Expiration)OPRO-101/00884883005327/OPRO29061A(2029-06-30); OPRO-SP/00884883005358/OPRO2906SA(2029-06-30)
Amount recalled
1366

Where it was sold

Why it was recalled

Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH) recovery, which may lead to a delay in reporting patient PTH results.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Nov 4, 12:11 AM UTC

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