| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00556-1 |
| Product Name/Description |
Alinity c Proteins Standard. An in vitro diagnostic medical device (IVD).
List Number: 08P6701
Lot Number: 01594L823
Expiry Date: 31/05/2025
UDI: (01)00380740151324(17)250531 (10)01594L823
ARTG 205773
(Abbott Australasia Pty Ltd Diagnostic Division - Clinical chemistry-specific protein IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
Some customers have experienced Alinity c Proteins control values out of range high when calibrating the Alinity c A1- Antitrypsin Reagent Kit.
This problem has not been observed when calibrating the Alinity c A-1-AGP Reagent Kit.
The problem observed may cause a delay in generating patient results if the controls report out of the acceptance range.
To date, there have been no reports of adverse events related to this problem. |
| Recall Action |
Recall |
| Recall Action Instructions |
· Customers are to stop using Alinity c Proteins Standard lot 01594L823 and discard any remaining kits of lot 01594L823.
· Arrange with Abbott to obtain a refund for affected stock.
· Replacement inventory is available to order. |
| Contact Information |
1800 816 696 - Abbott Customer Support |