Medical device manufacturer, Roche, has issued a medical device safety alert concerning its Cobas u pack - International market only [GMMI / Part No: 06334601-001 cobas u pack International market only; All lots]
According to the manufacturer, the data for cobas u pack on cobas u 601 urine analyzer collected during its interference testing of selected drugs and endogenous substances in urine was deviated in some cases from the initially obtained data claimed in the current cobas u pack Instruction for Use (IFU) (V2.0) for the international market.
Users are therefore advised that the interference claims will be changed and IFU will be updated. The changed claims will be applicable for all current and upcoming lots of cobas u pack. The manufacturer states that an updated IFU are expected to be available in July 2021.Affected users should follow the advice shown on the customer letter that were provided by the manufacturer.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 Jun 2021