NEWS/UPDATES OUTSIDE OF THE EEA/UK

Field Safety Notice, request by one EU authority to hold/investigate                               April 2022

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Mycobacterial investigation ongoing, no growth/organisms found                                    June 2022

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Mycobacteria PCR and staining studies ongoing,

             possible DNA could not yet be positively identified by Canadian labs                  July 2022

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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

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