Elecsys® Anti-TSHR
Brand(s)
Last updated
Summary
Product
Elecsys® Anti-TSHR
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Elecsys® Anti-TSHR | 840177 | 08496609190 |
| Elecsys® Anti-TSHR | 840183 | 8496633190 |
| Elecsys® Anti-TSHR | 874011 | 8496633190 |
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
Roche Diagnostics GmbH
Sandhofer Strasse 116, Mannheim, Germany, 68305
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81394
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