Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 23364 |
| Brand Name: | ARCHITECT Clinical Chemistry System |
| Model: | ARCHITECT c4000, c8000, and c16000 |
| 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 Laboratories Limited |
| Issue: | The ARCHITECT pressure monitoring system helps identify errors during pipetting operations, and error messages are generated to alert the user, should a problem with this system occur. If the system is in the Running status when pressure monitoring error code 3586 to 3600 or 5381 is generated, the ARCHITECT takes appropriate action to protect the integrity of patient test(s). If communication is lost between the ARCHITECT and the pressure monitoring system, the processing module will be placed into the Stopped status until the issue can be addressed. This ensures all tests are monitored by the pressure monitoring system. If the user chooses to transition the ARCHITECT to the Running status without successfully resolving error codes 3580 to 3585 or 5381, there is the potential to generate incorrect results as the pressure monitoring system is inactive. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 20/7/2018 |
