Thermo scientific MAS Omni CARDIO — Class II medical device recall Z-0415-2026
Ongoing recall by Microgenics Corporation, reported 2025-11-05, distributed nationwide. The firm received complaints from customers reporting vial-to-vial variability when using the control with hig
| Recall number | Z-0415-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microgenics Corporation, Fremont, CA, United States |
| Recall initiated | 2025-10-01 |
| Classified | 2025-10-30 |
| Reported by FDA | 2025-11-05 |
| Distributed | Nationwide (US) |
| Quantity | 4,462 |
| UPC / GTIN / UDI-DI | 00884883011946, 00884883011953, 00884883011960, 00884883011977, 00884883011984, 00884883011991, 00884883012004 |
| Lot numbers | OCRD-101, OCRD-202, OCRD-303, OCRD27041, OCRD27042, OCRD27043, OCRD2704L, OCRD2704M, OCRD2704S, OCRD2704U |
| Model numbers | OCRD-101, OCRD-202, OCRD-303 |
| Expiration dates | 2027-04-30 |
Product
Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control
Reason for recall
The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0415-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.