Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 23752 |
| Brand Name: | Access hsTnI Reagent |
| Model: | |
| Affected: | Ref B52699 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 Cardiac Troponin T cross reactivity concentration of 253 ng/mL (253,000 pg/mL) previously listed in the Access hsTnI Instructions For Use (IFU) does not apply to samples with hsTnI concentrations less than 16 pg/mL (ng/L). |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 26/10/2018 |
