Device recall
Z-1322-2018: VITROS Immunodiagnostic Products TSH Reagent Pack
FDA device recall · Class III · Clinical Diagnostic Systems
Key facts
| Recall number (Z-number) | Z-1322-2018 |
|---|---|
| Recall event | 79508 |
| Product | VITROS Immunodiagnostic Products TSH Reagent Pack |
| Product code | JLW |
| Recalling firm | Clinical Diagnostic Systems |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 8, 2020 |
| 510(k) numbers | K083173 |
| FEI number | 3003939841 |
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