Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21993 |
| Brand Name: | i-STAT®/DE software |
| Model: | |
| Affected: | List number 08K46-01, 115200, Part number 047659-01, Software Version 2.8 |
| Software version: | |
| Recalling Organisation: | Abbott Laboratories (NZ) Ltd Unit D 4 Pacific Rise Mt Wellington Auckland 2025 |
| Contact Information: | 0800 656 233 |
| Manufacturer: | Abbott Point of Care Canada Ltd |
| Issue: | The manufacturer has determined the following: 1. Location, Operator, and Patient Lists stored in the i-STAT 1 handheld will not update after upgrading to i-STAT/DE version 2.8 from an earlier version. 2. Customized Reference Ranges, Action Ranges, and Custom Reportable Ranges are reset to factory default values when upgrading to i-STAT/DE version 2.8 from an earlier version. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 19/9/2017 |
