Medical device regulators have issued a warning over laboratory analysers used to test for HIV, tumour markers and other conditions amid fears they could produce errors.
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Medical Device Alert concerning Siemens Healthcare’s ADVIA Centaur and ADVIA Centaur XP models with the catalogue numbers 078-A001-xx, 078-A002R02, 078-A011-03, and 078-A011R03.
The warning comes amid fears of a potential failure of the wash interconnect circuit board, which could fail to detect that the ‘Wash 1’ bottle is empty resulting in credible but erroneous results reported on a number of tests. The fault could also lead to incorrect identification that the bottle is empty when actually full, causing the system to stop processing samples.
To resolve the problem, Siemens Healthcare is planning software and hardware updates, which will be available by the end of March.
In the meantime it advises trusts using the systems to monitor ‘Wash 1’ fluid levels manually, to replace the bottle before the fluid is depleted, and to clear incorrect status of error messages that prohibit testing.
For the MHRA warning, click here.
