Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 25406 |
| Brand Name: | Elecsys Troponin |
| Model: | |
| Affected: | Elecsys® Troponin T hs V2 (300 tests) and Elecsys® Troponin T hs (300 tests), Lots - 419260, 436777, 474941, Elecsys® Troponin T hs (300 tests), Lot - 429178 |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | Roche Diagnostics GmbH |
| Issue: | The manufacturer has received complaints regarding non-reproducible elevated results (highflyers) for specific reagent lots of Elecsys® Troponin T hs on cobas e 801. This updated Recall for Product Correction is to inform laboratories that Elecsys® Troponin T hs product code 08469873190 lot 474941can be used without restrictions and as such double determinations are no longer required for this reagent lot. Reagent lot 474941 is the current lot number in New Zealand stock. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 29/6/2020 |
