The Elecsys Anti-TSHR immunoassay is a three-step competitive… — Class II medical device recall Z-1009-2026
Ongoing recall by Roche Diagnostics Operations, Inc., reported 2026-01-14, distributed nationwide. Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may le
| Recall number | Z-1009-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2025-11-21 |
| Classified | 2026-01-02 |
| Reported by FDA | 2026-01-14 |
| Distributed | Nationwide (US) |
| Quantity | 1,300 cassettes |
| Lot numbers | 02/26, 05/26, 08496609190, 08496633190, 10/26, 840177, 840183, 874011 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1009-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.