Medical device manufacturer, Roche Diagnostics, has issued a medical device safety alert concerning its COBAS INTEGRA 400 plus and cobas c 111 analyzer. [GMMI (Device Identifier): COBAS INTEGRA 400 plus analyzer with ISE (03245233001); COBAS INTEGRA 400 plus analyzer without ISE (04922859001); cobas c 111 with ISE (04777433001); cobas c 111 without ISE (04528778001); CLEAN {Cleaner Cassette, COBAS INTEGRA 400 plus} (20764337322); CLEAN {Cleaner- Special Wash Requirements, cobas c111} (04774248190)]
Newly generated measurements at the manufacturer revealed additional carryover for several tests on the COBAS INTEGRA 400 plus and cobas c 111 analyzer. The internal findings for a number of tests show that the product specifications were not met. The recommended wash steps were either insufficient or missing altogether.
According to the manufacturer, it cannot be excluded that incorrect high results were generated in case of carry over. A medical risk cannot be excluded
Customers are advised to run one or more offenders in combination with the affected victim applications need to install the required carryover evasions until the Test Application Software (TAS) and Extra Wash Cycle (EWC) lists are updated. For customers not running the affected tests no action is required.
The observed carryover will be averted by additional EWCs. For some test combinations a needle assignment is applicable. For COBAS INTEGRA 400 plus relevant changes are included in the upcoming TAS, solving the primary and secondary carryovers; the update is planned for end of Dec 2018. The updated EWC List is part of the updated Instructions for Use (IFU) for the Cleaner Cassette (V 8.0), which will be available in Q1/2019. The updated EWC list for cobas c 111 is part of the updated IFU for the Cleaner (V 6.0) that will be published in Q1/2019.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 Dec 2018