Recall Monitor
Health Products

Elecsys® Anti-TSHR

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: Elecsys® Anti-TSHR
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Model or catalogue numberLot or serial numberAffected products
8496633190874011Elecsys® Anti-TSHR
8496633190840183Elecsys® Anti-TSHR
08496609190840177Elecsys® Anti-TSHR

Issue

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.

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