| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00765-1 |
| Product Name/Description |
Alinity i HBsAg Controls and ARCHITECT HBsAg Controls. An in vitro diagnostic medical device (IVD).
Alinity i HBsAg Controls
List Number: 08P0810
Lot Number: 59044FZ00
UDI (01) 00380740130152 (17) 250115 (10)59044FZ00
ARCHITECT HBsAg Controls
List Number: 6C36-10
Lot Numbers: 60109FZ00 and 59039FZ00
UDI (01)00380740009496 (17)250115 (10)60109FZ00 and (01)00380740009496
(17) 250115 (10)59039FZ00
ARTG 215423
(Abbott Australasia Pty Ltd Diagnostic Division - Hepatitis B virus IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
Some positive control 2 vials of Alinity i HBsAg Control Kit, ARCHITECT HBsAg Control Kit, may contain a fungal contaminant which could result in aspiration errors.
Abbott received complaints associated with this issue due to aspiration errors and/or material clogging the dispensing tip of the Positive Control 2 (PC2) vial, also with reports of visible material in the PC2 component only.
There is no impact to patient results and to date, there have been no reports of adverse events related to this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers should immediately discontinue use of and destroy all inventory of Alinity i HBsAg Control Kit, LN 08P0810 lot number 59044FZ00 and ARCHITECT HBsAg Control Kit, LN 6C36-10 lot numbers 60109FZ00 and 59039FZ00 according to thier local procedures.
• Immediately contact ther Abbott Ambassador or Customer Service on 1800 816 696 (Australia) to order replacement material. Product replacement will be provided by Abbott. |
| Contact Information |
1800 816 696 - Abbott Customer Support |