| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00573-1 |
| Product Name/Description |
Bacterial Vaginosis Test and 2San Pregnancy Kit Midstream
Batch/Lot/Serial Number(s): VPH23030003, VPH23030001 & HCG23030074, HCG23040041
Expiry Dates: Expiry Date(s): 02-2025 & 02-2026
ARTG: N/A (product was not on the register) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
17/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
2San branded Bacterial Vaginosis and Pregnancy Kit Midstream products imported in 2023 were not included in the Australian Register of Therapeutic Goods (ARTG) at the time of supply.
There is no anticipated risk to product quality or patient safety. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers should inspect your stock and quarantine affected stock of batches VPH23030003, VPH23030001 & HCG23030074, HCG23040041 on hand to prevent further use.
Destroy affected stock once confirmed by 2San. |
| Contact Information |
raymond.lee@2san.com - 2San |