Recall Z-0159-2027 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Microgenics Corporation
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
| Date | Oct 15, 2026 (initiated Aug 17, 2026) |
| Status | Open, Classified |
| 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 |
| Action | On 8/17/2026, recall notices were emailed to customers asking them to do the following: 1) If the variability of the material (PTH Analyte) exceeds your laboratory's specification, dispose of the material. of the material in accordance with local, regional, and national regulations. 2) Contact TechService.mgc@thermofisher.com for any additional support. 3) Customers using the affected product can continue to use the product as long as it meets their laboratory's specification and continue monitoring performance of PTH analyte. 4) This recall notice needs to be passed to anyone within your or |
| Quantity | 1366 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.