Device recall
Z-0061-2019: VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997
FDA device recall · Class II · Ortho Clinical Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-0061-2019 |
|---|---|
| Recall event | 80717 |
| Product | VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997 |
| Product code | JLW |
| Recalling firm | Ortho Clinical Diagnostics Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K081543 |
| 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