Elecsys® Anti-TSHR recall in Canada: Performance issues
In plain language
This recall involves Elecsys® Anti-TSHR, a medical device, sold in Canada. It's being recalled because of performance issues that cause test results to vary. Contact the manufacturer for more information.
What to do
- Contact the manufacturer if you require additional information.
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Affected products
Elecsys® Anti-TSHR
Model: 08496609190, 8496633190
Lot: 840177, 840183, 874011
Why this matters
Performance issues
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: 840177, 840183, 874011
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 08496609190, 8496633190
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Performance issues
What should consumers do?
Contact the manufacturer if you require additional information.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Performance issues
When was this product recalled?
This product was recalled on December 23, 2025.
Is the ROCHE DIAGNOSTICS GMBH brand affected by this recall?
Yes, ROCHE DIAGNOSTICS GMBH products are affected by this recall. This recall involves Elecsys® Anti-TSHR, a medical device, sold in Canada. It's being recalled because of performance issues that cause test results to vary. Contact the manufacturer for more information.