Device recall
Z-0557-03: CARTON LABEL: ''TDM Performance Verifier I''; 6 x 2 mL vials **** Catalog Number…
FDA device recall · Class III · Ortho-Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-0557-03 |
|---|---|
| Recall event | 25319 |
| Product | CARTON LABEL: ''TDM Performance Verifier I''; 6 x 2 mL vials **** Catalog Number 896 2540 **** Made in USA by Ortho-Clinical Diagnostics , Inc., 100 Indigo Creek Drive, Rochester, NY 14626 **** |
| Recalling firm | Ortho-Clinical Diagnostics |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 14, 2003 |
| 510(k) numbers | K013899 |
| FEI number | 1000136573 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
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