| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00059-1 |
| Product Name/Description |
The Alinity s System. An in vitro diagnostic medical device (IVD)
List Number: 06P16.01
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 |
23/01/2024 |
| Responsible Entity |
|
| Reason/Issue |
Abbott has identified an instance of a hardware issue (out-of-specification standoffs) associated with the assembly of the Alinity System incubation track.
This may lead to Reaction Vessel (RV) jams and/or splashing within the RV as it transitions from the incubation track to the process path during instrument operation. Splashing within an RV has the potential to affect test results.
No Adverse events due to this issue have been reported in Australia. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are requested to continue operating and maintaining the Alinity System as described within the System Operations Manual. There are no additional necessary actions to be taken by customers.
Abbott representatives will inspect all Alinity s Systems to identify any standoffs out of specification. If any standoffs are identified as incorrect, Abbott will work with impacted customer sites to schedule the required service activities to replace these standoffs. |
| Contact Information |
1800 816 696 - Abbott Customer Support |