translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Recall / Field Safety Notice

mdprc 165 07 13 002

2015-04-29

Saudi Arabia

SFDA

https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=7560

Radiometer has become aware that some d788 pco2 membranes can cause biased measurement results on patient results as well as qc results. the bias can be seen after the replacement of the membrane, and will be positive in the low range and negative in the high range. there is a risk of wrong diagnosis and maltreatment of patients for biased measurement results in the high range , root cause investigation is still in progress, but the preliminary root cause is variations in the thickness of a silicone layer used in the membrane units. the error was discovered through internal testing on blood and qc material in connection with a capa raised to document the investigation of an issue regarding low qc comparison results. ....................... bfarm update action: your local radiometer representative has now installed the improved sealing ring for the ph electrode in your abl700 and abl800 series analyzers. the improved sealing ring may be identified by its blue color.