| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00055-1 |
| Product Name/Description |
Vacuette Minicollect Complete 1ml Sodium Citrate 3.2%. An in vitro diagnostic medical device.
Item Number: 450556
Batch Number: A171144P
ARTG Number: 256074
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
Interpath have become aware of an issue regarding inconsistent volumes of citrate present in certain batches of the Vacuette Minicollect Complete 1mL Sodium Citrate 3.2% tubes which may affect patient results. |
| Recall Action |
Recall |
| Recall Action Instructions |
Interpath is advising customers to inspect stock and quarantine all tubes of batch A171144P. Customers should then complete the reply form provided with the Customer Letter so Interpath may arrange for stock to be recovered and replacement stock issued.
This action has been closed out on the 27/09/2018. |
| Contact Information |
03 9457 6277 - Interpath Services |