Database updated: 3 November 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28467 |
| Brand Name: | ARCHITECT Systems |
| Model: | ARCHITECT i1000SR, ARCHITECT i2000SR, ARCHITECT i2000, ARCHITECT c4000, ARCHITECT c8000, ARCHITECT c16000 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Abbott Laboratories (NZ) Ltd Unit D 4 Pacific Rise Mt Wellington Auckland 2025 |
| Contact Information: | 0800 656 233 |
| Manufacturer: | Abbott Laboratories |
| Issue: | The manufacturer has identified three potential performance issues for the ARCHITECT Software version 9.41 and earlier. Abbott is releasing ARCHITECT Software versions 9.45 and 9.50 to correct these issues. During the investigation, more issues have been found, such as: 1. Unable to process test, internal wash pressure (x) error (y) pipettor'. 2. Carryover of incorrect calibrator sample volumes. 3. i-Automated Reconstitution Module (iARM) loses communication with the System Control Center (SCC). 4. Erroneous ICT calibration curves. 5. Quality control (QC) data are not deleted, and calibration curves remain active. 6. 1ml Syringes wear over time. 7. Control flags are missing. 8. Signal spikes during the read cycle. 9. Abnormal optics reads. 10. Tracking multiple RVC errors. 11. Incorrect aspiration issue. 12. Inconsistent rounding of configured linearity values. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 14/10/2021 |
