Recall Z-0159-2027— Microgenics Corporation

Name: FDA recall Z-0159-2027
Creator: U.S. Food and Drug Administration
Published: 2026-08-17

Class II · Ongoing

Class II FDA medical device recall by Microgenics Corporation, initiated 2026-08-17. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 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..

Recalling firm: Microgenics Corporation
Classification: Class II
Status: Ongoing
Initiated: 2026-08-17
Firm location: Fremont, CA, United States

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.