- Recalling firm
- Microgenics Corporation
- 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.
- Affected products (lot / model / serial)
- REF/UDI-DI/Lot(Expiration): OPRO-101/00884883005327/OPRO29061A(2029-06-30); OPRO-SP/00884883005358/OPRO2906SA(2029-06-30)
- Units affected
- 1366
- Distribution pattern
- 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 location
- Fremont, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0159-2027
- Recall initiated
- August 17, 2026
- FDA classification date
- October 15, 2026
- FDA report date
- October 21, 2026
- FDA event ID
- 99736
- Last updated on HTM Vibe
- October 27, 2026
