| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00172-1 |
| Product Name/Description |
ARCHITECT Anti-HBc II Reagent Kit. An in vitro diagnostic medical device (IVD)
List Number: 8L44-25
Lot Numbers:42072LI00, 42072LI01 (Expiry Date:28-May-2015) & 42253LI00, 42253LI01 (Expiry Date:30-Jun-2015)
List Number: 8L44-30
Lot Numbers:42255LI00, 42255LI01(Expiry Date:30-Jun-2015)
List Number: 8L44-35
Lot Numbers: 42256LI00 (Expiry Date:30-Jun-2015)
ARTG Number: 200673 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
The ARCHITECT Anti-HBc II assay shows lower calibrator, control and sample RLU values, potentially leading to reduced specificity and increased false reactive results. |
| Recall Action |
Recall |
| Recall Action Instructions |
Abbott Diagnostics is requesting the customers to discontinue use of the listed lots and destroy any remaining inventory of these lots according to their laboratory procedures. Abbott Diagnostics is recommending discussing the content of this letter with the laboratory management and communicating this information to the health care providers to determine if any further testing is needed. This action has been closed-out on 17/08/2016. |
| Contact Information |
1800 816 696 - Abbott Customer Support |