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                                 July 2022

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Field Safety Notice - Product update for countries outside of the EE -

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

             clinical events at normal/historical rates                                                                    August 2022

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Field Safety Notice - No Canadian PCR lab can reproduce the German results.  Along with                            
no growth in dozens of devices, BioIntegral can no longer recommend any 

device restrictions.  Probably a false alarm, they were sterile the whole time.                   March 2023

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One year later: no change in device performance and safety                                               April 2023

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