Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 27579 |
| Brand Name: | IRON2 |
| Model: | on cobas c 311/501/502 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | Roche Diagnostics GmbH |
| Issue: | Several customer complaints have been received regarding the increased recovery of controls and discrepant elevated results for the IRON2 on cobas c 311/501/502. Internal investigations confirmed the issue and revealed a systematic sample drift up to +4.7 µmol/L absolute for IRON2 over the entire measuring range. The bias increases with the number of tests performed from one cobas c pack without further calibration. The first measurements are not affected while the last sample can exhibit the maximal observed bias. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 12/4/2021 |
