Elecsys® Anti-TSHR
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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
Roche Diagnostics GmbH
Sandhofer Strasse 116, Mannheim, Germany, 68305
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