Device recall
Z-0558-03: Vitros Immunodiagnostic Products *** UNIVERSAL WASH REAGENT *** for in vitro…
FDA device recall · Class III · Ortho-Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-0558-03 |
|---|---|
| Recall event | 25394 |
| Product | Vitros Immunodiagnostic Products *** UNIVERSAL WASH REAGENT *** for in vitro diagnostic use only. The product is sold in cartons containing 2 bottles (5 liters each). CAT 838 9793 |
| Recalling firm | Ortho-Clinical Diagnostics |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 3, 2003 |
| 510(k) numbers | K964310 |
| 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