Device recall
Z-0739-2020: 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to…
FDA device recall · Class II · Ortho Clinical Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-0739-2020 |
|---|---|
| Recall event | 84123 |
| Product | 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using the VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems. |
| Product code | DCF |
| Recalling firm | Ortho Clinical Diagnostics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 13, 2020 |
| FEI number | 2250051 |
At a glance
- None 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