Device recall
Z-0415-2026: Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control…
FDA device recall · Class II · Microgenics Corporation
Key facts
| Recall number (Z-number) | Z-0415-2026 |
|---|---|
| Recall event | 97745 |
| 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 |
| Product code | JJY |
| Recalling firm | Microgenics Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3010939897 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database