Medical device manufacturer, Roche Diagnostics GmbH issued a medical device safety alert concerning the following products:
According to Roche, some of the lots listed above may have micro-leakage. Internal investigation revealed that the frequency of the micro-leakage showed in 1 out of 8000 cassettes. l
Users are suggested to check whether the cellophane wrapping of the cassettes are wet before loading to the reagent manager. According to Roche, all further product lots will undergo a 100% leakage check during the manufacturing process, and reimbursement or replacement can be offered in case of product leaking.
According to the local supplier, Roche Diagnostics (Hong Kong) Limited, the affected products have been distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 February 2013