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

Field Safety Notice - Hold lifted for all territories outside of the EEA/UK                           July 2022

Field Safety Notice - Product update for countries outside of the EEA/UK -

             no hold/restrictions, no bacterial culture growth, bacterial stains negative,

             clinical events at normal/historical rates                                                                  August 2022