Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15617 |
| Brand Name: | Abbott i-Stat PT/INR Cartridge |
| Model: | Model: 3P89-24 |
| Affected: | Lots from C13139 to C13270A |
| 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 that a range of i-STAT PT/INR cartridge lots have the potential to exhibit incorrectly elevated results. Internal studies have demonstrated that i-STAT PT/INR results are eleveated by an average of approxiamtely 10% as compated to the International Reference Preparation (rTF/09) in the therapeutic range of 1.8 to 3.0 INR. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 5/11/2013 |
