Microgenics Corporation: Multi-analyte Controls, All Kinds (assayed)
Recall Summary Microgenics Corporation is recalling specific lots of MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control products used in medical laboratories. The controls have inconsistent quality between vials that causes low parathyroid hormone (PTH) test results, which may delay when laboratories report patient PTH test results to doctors. The recall affects laboratory facilities nationwide in the U.S. and in several other countries.
- Recalling firm
- Microgenics Corporation
- Product
- 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
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-17
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/b6976d2e-bdc1-4af6-8629-512d5acb14e3