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Z-0159-2027Class II

Microgenics Corporation

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Microgenics Corporation
Product type
Device
Status
Ongoing
Report date
2026-10-21
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.
Firm state
CA
Product quantity
1366
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
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.

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

Code / lot info

REF/UDI-DI/Lot(Expiration): OPRO-101/00884883005327/OPRO29061A(2029-06-30); OPRO-SP/00884883005358/OPRO2906SA(2029-06-30)

Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →