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