The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and el
FDA device recall Z-1009-2026 · posted 2026-01-02 · Open, Classified
Recall details
- Recalling firm
- Roche Diagnostics Operations, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- JZO
- Quantity affected
- 1300 cassettes
- 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.
- Date initiated
- 2025-11-21
- Date posted
- 2026-01-02
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Elecsys Anti-TSHR (K193313) | Roche Diagnostics | 2020-02-27 |