FDA Device recall Z-1009-2026
The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminesce…
- FDA Device
- Class II
- ongoing
- Published 2026-01-14
On 2026-01-14 the FDA classified a Class II recall of The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminesce… by Roche Diagnostics Operations, citing issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1009-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-21 |
| Published | 2026-01-14 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
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 porcine TSH receptor (pTSHR) and biotinylated anti-pTSHR mouse monoclonal antibody.
Reason
Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.
Identifiers
| code_info | 08496633190 lot 840183 exp. 02/26 08496633190 lot 874011 exp. 10/26 08496609190 lot 840177 exp. 05/26 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1009-2026%22
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