Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20295 |
| Brand Name: | Beckman Coulter Access Free T3 reagent |
| Model: | A13422 |
| Affected: | Lot Nos: multiple (all lots manufactured post June 2015) |
| 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: | Specific lots manufactured post June 2015 of the Access Free T3 Reagent demonstrate an upward shift in patient results. Patient sample results will shift upward by approximately 10.4% across the reference interval when compared to the results generated with reagent lots manufactured prior to the June 2015 design change. Additional assay performance characteristics are not affected. Due to matrix differences, QC values may not demonstrate a shift. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 21/6/2016 |
