Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28175 |
| 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: | A subsequent investigation has determined that sample-to-sample carryover may also occur under certain conditions confirming that intra-assay carryover encompasses into-pack and sample-to-sample carryover. Through these subsequent studies, BEC determined that clinically significant sample-to-sample carryover can occur in hsTnI samples that are tested after a sample with a cTnI concentration >55,000 pg/mL (ng/L). |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 22/2/2022 |
