Device recall
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
- Recall number
- Z-0159-2027
- Event id
- 99736
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Microgenics Corporation
- Report date
- Oct 21, 2026
- Posted
- Oct 15, 2026
- Initiated
- Aug 17, 2026
- Center classification date
- Oct 15, 2026
- Product code
- JJY
- Device type
- Multi-Analyte Controls, All Kinds (Assayed)
- 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.
- Root cause
- Process change control
- Quantity
- 1366
- Code info
- REF/UDI-DI/Lot(Expiration): OPRO-101/00884883005327/OPRO29061A(2029-06-30); OPRO-SP/00884883005358/OPRO2906SA(2029-06-30)
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Fremont, CA, United States