| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00399-1 |
| Product Name/Description |
Gene Amplification Reagent – Lynoamp BC. An in vitro diagnostic medical device.
Product Code: BA895684
Lot Number: ZS5011
ARTG Number: 214482 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
The Lynoamp BC is used for the detection of CK19 mRNA in surgically removed regional lymph node in breast cancer (used for an aid to the diagnosis of lymph node metastasis in breast cancer). It was found by the manufacturer that a specific lot of Lynoamp BC (Lot Number ZS5011) showed an unexpected high positive rate. |
| Recall Action |
Recall |
| Recall Action Instructions |
The customer has already been advised to dispose the affected unit and will be given replacement stock. This action has been closed-out on 26/05/2017. |
| Contact Information |
02 9906 2984 - Brandwood Bio Medical |