| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01075-1 |
| Product Name/Description |
Alinity i HBsAg Reagent Kit. An in vitro diagnostic medical device (IVD)
Lot number: 51503FN00
ARTG 215423
(Abbott Australasia Pty Ltd Diagnostic Division) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/12/2023 |
| Responsible Entity |
|
| Reason/Issue |
Abbott has identified a few cartridges within Alinity i HBsAg Reagent Kit, list number 08P0852, lot 51503FN00 that may exhibit variability in relative light unit response and concentration values which may result in controls out of range, and/or incorrect patient results.
Positive control out of range low results and/or negative control out of range high results could occur when using an impacted cartridge.
To date, there have been no reports of adverse events related to this issue in Australia. |
| Recall Action |
Recall |
| Recall Action Instructions |
- Immediately discontinue use of Alinity i HBsAg Reagent Kit, lot number 51503FN00.
- Destroy all inventory of lot number 51503FN00 received according to local procedures.
- Immediately contact Customer Support to order replacement material.
- Follow laboratory protocol regarding the need for review of previously reported patient results using lot number 51503FN00.
This action has been closed out on 22/4/2024. |
| Contact Information |
1800 816 696 - Abbott Customer Support on |