Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21111 |
| Brand Name: | Abbott i-STAT1 Analyzer Software |
| Model: | |
| Affected: | JAMS142E |
| 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 |
| Brand Name: | Abbott Celite ACT Cartridges |
| Model: | |
| Affected: | 03P86-25 |
| 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 |
| Brand Name: | Abbott Kaolin ACT Cartridges |
| Model: | |
| Affected: | 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: | The manufacturer has determined that Celite ACT and Kaolin ACT cartridges may produce falsely low results when very high clotting time samples are tested. Patient samples with a measured clot time of >853 seconds for Celite and >1134 seconds for Kaolin may display results of approximately 100 to 200 seconds while using JAMS142E. The typical therapeutic range of the i-STAT ACT assay is 200 to 600 seconds. Results obtained within this range are unaffected. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 15/2/2017 |
