TemporaryFDAOngoing
Can cause harm that is usually temporary.
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
Check the device or its packaging for
REF/UDI-DI/Lot(Expiration): OPRO-101/00884883005327/OPRO29061A(2029-06-30); OPRO-SP/00884883005358/OPRO2906SA(2029-06-30)
- Why
- 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.
- Distributed
- 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.
- Company
- Microgenics Corporation
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0159-2027 · retrieved 15 October 2026
Read the official notice