| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01184-1 |
| Product Name/Description |
FIDS dsDNA Kit
(used for the detection and monitoring of Systemic Lupus Erythematosis (SLE)). An in vitro diagnostic medical device (IVD)
Product Code: BM-MX005-s
Lot Number: LE124535
Expiry: 31 Jan 2018
ARTG Number: 198370
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
Diagnostic Solutions has been informed by the manufacturer that there is an issue with the stability of the calibrator in the kit. An increase of fluorescence was observed during the ageing of the calibrator and therefore a decrease in patient results. |
| Recall Action |
Recall |
| Recall Action Instructions |
Diagnostic Solutions to advising users to inspect stock and destroy any remaining kits of the affected lots. Affected stock will be replaced with unaffected product.
It is recommended that previously reported results are reviewed at the discretion of the laboratory director. This action has been closed-out on 11/05/2017. |
| Contact Information |
1300 788 003 - Diagnostic Solutions Customer Service |