Field Safety Notices about Ortho biovue system cassette for immunohematology

Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Croatia.

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.