| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00048-1 |
| Product Name/Description |
The Alinity s System. An in vitro diagnostic medical device (IVD)
List Number: 06P16-01
Serial Number: Multiple serial numbers
ARTG 285249
(Abbott Australasia Pty Ltd Diagnostic Division - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/01/2024 |
| Responsible Entity |
|
| Reason/Issue |
Abbott has identified two potential issues that may be exhibited when operating the Alinity s System software version 2.8.2 and prior.
Issue 1 - An incorrect Laboratory Automation System aspiration location calibration can cause misassigned test results, i.e., the result assigned to the unique sample identifier (SID) originated from another SID onboard the instrument.
Issue 2 - A bent or mispositioned sample pipettor probe off target 1.5 -2.0mm has the potential to adversely affect pipetting accuracy and cause incorrect test results (false positive).
No adverse events due to this issue have been reported in Australia. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
An Abbott representative will be scheduling a mandatory upgrade of Alinity s System(s) to install software version 2.9.0 to prevent these potential issues and improve the system.
Software available: Jan 2024
There are no additional necessary actions to be taken by customers. |
| Contact Information |
1800 816 696 - Abbott Customer Support |