NEWS/UPDATES OUTSIDE OF THE EEA/UK
Field Safety Notice, request by one EU authority to hold/investigate April 2022
Mycobacterial investigation ongoing, no growth/organisms found June 2022
Mycobacteria PCR and staining studies ongoing,
possible DNA could not yet be positively identified by Canadian labs July 2022
Product update for countries outside of the EEA/UK - no restrictions, no bacterial culture growth,
bacterial stains negative, clinical events at normal/historical rates August 2022