Device recall
Z-0844-2019: Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of…
FDA device recall · Class II · Ortho Clinical Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-0844-2019 |
|---|---|
| Recall event | 81767 |
| Product | Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma |
| Product code | JIS |
| Recalling firm | Ortho Clinical Diagnostics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 6, 2024 |
| 510(k) numbers | K033300 |
| FEI number | 2250051 |
At a glance
- 1–9 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