The Elecsys Anti-TSHR immunoassay is a three-step… recallZ-1009-2026 · Roche Diagnostics Operations, Inc. · initiated Nov 21, 2025
Class II Open, Classified All recalls posted in January 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Roche Diagnostics Operations, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
Firm notified customers on November 21, 2025 via Urgent Medical Device Correction notices. Customers using the cobas e 402/801 and cobas e411 were instructed to immediately discontinue using the impacted lots outlined in the UMDC and switch to the new unaffected lot numbers listed in the communication.
Recall details
- Recall number
- Z-1009-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Nov 21, 2025
- Posted by the FDA
- Jan 2, 2026
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 1300 cassettes
- Product code
- JZO
- FDA submissions
- K193313
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, ME, MI, MN, NC, NJ, NM, NY, OH, PA, PR, TN, TX, UT, WA, WV.
Product description
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.
Code information (models, lots, serial numbers)
08496633190 lot 840183 exp. 02/26 08496633190 lot 874011 exp. 10/26 08496609190 lot 840177 exp. 05/26
Other devices under the same FDA submission
2 devices cleared under K193313 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Elecsys Anti-TSHR 08496609190Roche Diagnostics GmbH · SYSTEM, TEST, THYROID AUTOANTIBODY31 reports
- Elecsys Anti-TSHR 08496633190Roche Diagnostics GmbH · SYSTEM, TEST, THYROID AUTOANTIBODY16 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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