Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 22433 |
| Brand Name: | i-STAT Alinity Instrument i-STAT Alinity Analyzer Software |
| Model: | with software version OSi05 (JAMS 79A / CLEW D34). |
| Affected: | |
| 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: | Through a combination of internal studies and customer reports, the manufacturer has determined that the following may occure: 1. An increased frequency of Quality Check Failure code 90-02 when testing i-STAT cartridges with the i-STAT Alinity software version OSi05 (JAMS 79A / CLEW D34). 2. When testing with i-STAT cartridges that report pH, pCO2 and pO2, an i-STAT Alinity instrument with software version OSi05 (JAMS 79A / CLEW D34) that is customized to correct for user entered patient temperature may report incorrect pH and/or pCO2 results. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 12/1/2018 |
