Device recall
Z-1009-2026: The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with…
FDA device recall · Class II · Roche Diagnostics Operations, Inc.
Key facts
| Recall number (Z-number) | Z-1009-2026 |
|---|---|
| Recall event | 98103 |
| Product | The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocomplex of solubilized… |
| Product code | JZO |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K193313 |
| FEI number | 1823260 |
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