| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00563-1 |
| Product Name/Description |
Prosigna Breast Cancer Prognostic Gene Signature Assay. An in vitro diagnostic medical device (IVD)
Product Codes: NANPROSIGNA-002, NANPROSIGNA-003
Lot Number: 0100531017
ARTG Number: 226487 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
8/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer NanoStrong Technologies has identified a quality issue with a single lot of the Prosigna kit that may result in an error 35 of the Prosigna Assay due to high background. A specific failure mode has been observed at an elevated rate with Prosigna kit lot 0100531017. This failure mode is pre-emptively identified by the embedded software, resulting in the output of an error by the system without the output of any test result. If this failure mode is experienced, a result for the sample would not have been obtained. If a test result was generated using this lot of kits, those results are not affected. |
| Recall Action |
Recall |
| Recall Action Instructions |
Bio-Strategy is advising users to quarantine and place all unused kits from lot 0100531017 in a box at ambient temperature ready for collection. Bio-Strategy will arrange for the collection and replacement of unused kits.
This action has been closed out on 18/10/2018 |
| Contact Information |
1800 008 453 - Bio-Strategy |