AFSSaPS issues regulation news on Advance Bionics, Abbott:
This article was originally published in Clinica
Product withdrawal notices for Advanced Bionics' cochlear implants, the Clarion 1.2, Clarion CII Ear and the Hires 90K are among those posted this month by the French healthcare products safety agency (AFSSaPS). The company has asked for all non-implanted products to be returned because of the identification in some implants of a higher-than-normal humidity level, which could lead to these devices malfunctioning. AFSSaPS' notices this month include a statement from Abbott Diagnostics saying that there are new acceptability limits for its i-STAT level 1 and i-STAT level 3 analysers.