Medical Devices

ORTHO BioVue System Cassette immunohematology


The Agency for Medicinal Products and Medical Devices (HALMED) has received from the medical device manufacturer Ortho Clinical Diagnostics, England, an information about the addendum to the safety corrective action regarding the ORTHO BioVue System Cassette for immunohematology.

The manufacturers has provided users with the revised risk assessment and table of possible impact on test results.

The safety information for users with the list of affected batches is available here.