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

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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

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NOTICE TO DISTRIBUTORS:  No devices are to be shipped outside                               Jan 2023

your jurisdictions.  There remain restrictions on devices in various countries,

particularly the EEA.  While any holds on devices may be lifted in your home countries,

those devices are no cleared for shipment or sale to others.

   

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