CanadaThe affected product is the Elecsys Anti‑TSHR assay (Roche Diagnostics) identified by lot/serial numbers 840177, 840183, and 874011 and catalogue/model numbers 08496609190 and 8496633190. It was recalled because internal reviews found results can vary by instrument platform (Cobas e 801/e 402 versus Cobas e 411) and results can vary by calibrator lot (affecting only the Cobas e 411). Roche will replace impacted reagents free of charge; contact the manufacturer for additional information.
What's being recalled
Companies: Roche Diagnostics GmbH, Sandhofer Strasse 116, Mannheim, Germany, 68305.
How to identify it
Affected products: Elecsys® Anti-TSHR; Lot or serial number: 840177; Model or catalogue number: 08496609190
Affected products: Elecsys® Anti-TSHR; Lot or serial number: 840183; Model or catalogue number: 8496633190
Affected products: Elecsys® Anti-TSHR; Lot or serial number: 874011; Model or catalogue number: 8496633190
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)