Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 22423 |
| Brand Name: | i-STAT Kaolin ACT Cartridges |
| Model: | |
| Affected: | List number 03P87-25 |
| Software version: | |
| Recalling Organisation: | Abbott Australasia Pty Ltd (NZ) Abbott Laboratories NZ 4 Pacific Rise, Mt Wellington Auckland 1060 |
| Contact Information: | 61 2 93849717 |
| Manufacturer: | Abbott Point of Care Canada Ltd |
| Issue: | To regards to the drug aprotinin (Trasylol), which was previously withdrawn from many markets but may be available in some countries/regions. Internal studies, have identified that the i-STAT Kaolin ACT test may be prolonged immediately after the administration of an initial full dose aprotinin bolus of 400 kallikrein inhibitor units (KIU)/mL. Once the drug has fully distributed throughout the body there is no impact on the ACT result reported. For aprotinin, 200-280 KIU/mL is considered a therapeutic or steady state concentration during CPB. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 11/1/2018 |
