Official recall record
Elecsys® Anti-TSHR
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-12-23
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Internal reviews have confirmed two related problems with the Elecsys® Anti-TSHR assay. The test results for the same patient sample vary by instrument platforms (Cobas e 801/e 402 and Cobas e 411) or results vary by calibrator lot (only affecting Cobas e 411 platform). Roche will replace all of the impacted reagents still remaining in your inventory, free of charge. All newly manufactured lots are not impacted.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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