Important Safety Alerts

Medical device manufacturer, Roche Diagnostics, has issued a medical device safety alert concerning its immunochemistry modules E170 (catalogue number: 04998642001), cobas e 601 (catalogue number: 04745922001) and cobas e 602 (catalogue number: 05990378001). The systems affected are MODULAR ANALYTICS EVO, cobas 6000 analyzer series and cobas 8000 modular analyzer series.

The manufacturer is informing customers that a sample mismatch may occur in the immunochemistry modules (cobas e 602, cobas e 601 and E170 modules) due to a software limitation. The sample mismatch is only occurs if the following conditions are simultaneously met (i.e. very rare occurrence):

• Immunochemistry module (cobas e 602, cobas e 601 and E170 modules) is included in its respective system (cobas 8000 modular analyzer series, cobas 6000 analyzer series, MODULAR ANALYTICS, MODULAR ANALYTICS EVO)
• The "Module Rack Buffer setting" ≠"1" → Two or more sample racks stay in the idling/processing line (L-Line) consecutively during operation.
• One rack (Rack A) is undergoing sampling and the following rack (Rack B) is waiting for measurement.
• The Gripper (T/V Carrier) fails to pick up the last vessel (cup) on Rack A. As a consequence, the measurement for the sample in the last vessel which failed to be picked up is canceled and the warning "Tip/Cup pick up error" (Caution Level) is issued.
• Sample position 1 of the following rack (Rack B) is empty or has no test order for the immunochemistry module.

According to the manufacturer, the root cause has been identified and a newly software version fixing that issue will be released by Nov 2017. Meanwhile and until the new software version is available, the local supplier will contact the user and change the setting for the "Module Rack Buffer setting" to 1. When the new software version is available it will be installed as a mandatory update to the system.

The manufacturer advises users to use the interim solution of the Field Safety Notice until the local supplier changes the setting for the "Module Rack Buffer setting" to 1

According to the local supplier, the affected products, except MODULAR ANALYTICS EVO , are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 6 July 2017