Roche Diagnostics Operations, Inc.: Device Recall
Recall #Z-1009-2026 · 11/21/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1009-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Roche Diagnostics Operations, Inc.
- Status
- Ongoing
- Date Initiated
- 11/21/2025
- Location
- Indianapolis, IN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1300 cassettes
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.
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.
Distribution Pattern
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.
Other Recalls by Roche Diagnostics Operations, Inc.
- Class II: Risk 10/17/2024
- Class II: Risk 08/15/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.