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Elecsys® anti-tshr
Official notice
23 Dec 2025
Last checked
23 Dec 2025
An official Health Canada notice concerns Elecsys® anti-tshr. 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. Published 2025-12-23.
What to do now
Contact the manufacturer if you require additional information.
Recall number
81394
Official notice
2025-12-23
The hazard
The hazard
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.
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Roche Diagnostics.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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