Device recall
Z-2580-2016: VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product…
FDA device recall · Class III · ORTHO-CLINICAL DIAGNOSTICS
Key facts
| Recall number (Z-number) | Z-2580-2016 |
|---|---|
| Recall event | 74828 |
| Product | VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ UK For the in vitro quantitative measurement of thyroid stimulating hormone (TSH) in human serum and… |
| Product code | JLW |
| Recalling firm | ORTHO-CLINICAL DIAGNOSTICS |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 11, 2018 |
| 510(k) numbers | K083173 |
| FEI number | 3007111389 |
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