Device recall
Z-2366-2020: VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI #…
FDA device recall · Class II · Ortho-Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-2366-2020 |
|---|---|
| Recall event | 85652 |
| Product | VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600… |
| Product code | CIW |
| Recalling firm | Ortho-Clinical Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 22, 2021 |
| 510(k) numbers | K812027 |
| FEI number | 1000305840 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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