Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26346 |
| Brand Name: | Troponin I (TNIH) Flex® reagent cartridge |
| Model: | |
| Affected: | Lot numbers - 20008BB, 20035BC, 20135BB |
| Software version: | |
| Recalling Organisation: | Siemens Healthcare (NZ) Ltd Millennium Centre, Part Level 2, Building A 600 Great South Road Ellerslie AUCKLAND 1051 |
| Contact Information: | 0800 310 300 |
| Manufacturer: | Siemens Healthcare Diagnostics Inc |
| Issue: | The manufacturer has observed a negative bias across the Analytical Measurement Range of the Dimension Vista High Sensitivity Troponin I (TNIH) assay. The average bias observed for patient samples using the Dimension Vista TNIH lots when compared with a control TNIH lot was -20% for lot 20008BB and -23% for lot 20135BB. A maximum bias of -26% in patient samples around the 99th percentile with the lots 20008BB, 20035BC and 20135BB was observed. Quality Control will not detect the negative patient bias. TNIH lot 20008BB and lot 20035BC contain the same reagents therefore, performance of the two lots is equivalent. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 30/7/2020 |
