Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 25938 |
| Brand Name: | Access hsTnI Reagent |
| Model: | |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Beckman Coulter NZ Ltd Suite 2, Level 4 30 St Benedicts Street Newton AUCKLAND |
| Contact Information: | 0800 446 109 |
| Manufacturer: | Beckman Coulter Inc |
| Issue: | The manufacturer has determined that testing a sample with cardiac troponin I (cTnI) concentrations that are >270,000 pg/mL (ng/L) may cause carryover into the hsTnI reagent pack. The Access hsTnI quantifiable range is up to ~270,000 pg/mL (ng/L). |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 20/4/2020 |
