FDA-Device2026-10-21Class IIPROCESSING DEFECT

Microgenics MAS Omni IMMUNE PRO immunoassay control recalled for PTH recovery variability

OTHERNationwide distributionMedical devices

What this means

Certain vials of Microgenics MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control (Level 1, Lot OPRO29061A) show inconsistent quality from vial to vial. This variability can cause low recovery of parathyroid hormone (PTH) in lab testing, potentially delaying results that are reported to patients and doctors.

If you operate a clinical laboratory using Lot OPRO29061A (expiration 2029-06-30), check your inventory and do not use affected vials for patient testing.
Contact Microgenics Corporation for instructions on replacement or a refund.
Review any PTH test results already reported from this lot; contact your device supplier or the FDA if you need guidance on notification.

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The agency's original wording

Hazard

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.

Intended for

All ages

Illnesses reported

None reported

Sold states

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.

Affected count

1366

Manufactured in

46500 Kato Rd, Fremont, CA, United States

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0159-2027

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