Type of Product |
Medical Device |
TGA Recall Reference |
RC-2017-RN-00139-1 |
Product Name/Description |
Acecide Test Strips (used to monitor the acecide chemical concentration as part of the Olympus OER-AW endoscope reprocessing cycle)
All stock currently in the market
ARTG number: 170540 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
27/01/2017 |
Responsible Entity |
|
Reason/Issue |
During storage the acecide test strips may have been stored outside the manufacturer recommended 2-8°C for longer than 14 days. As a result, the shelf life of the test strips may be affected. Use of test strips that have not been stored according to the recommended conditions may alert users to change the acecide solution more often than required. |
Recall Action |
Recall |
Recall Action Instructions |
Customers are advised to check their inventory, quarantine, and dispose of any acecide test strips within their control. They will be provided with replacement stock for any affected inventory. Customers are also advised to ensure that the test strips must be stored between 2-8°C and that the test strip be used only after being brought to room temperature. This action has been closed-out on 01/03/2018. |
Contact Information |
1300 657 699 - Olympus |