The device with the reported false positive result was requested back for investigation; however, the customer discarded it.Since the device was not received, the allegation could not be confirmed.On page 12 of the instructions for use under limitations, it states the device cannot identify false positive results.There will be no corrective actions taken at this time as the complaint cannot be confirmed and root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Visby will continue to monitor for trends.Treatment/ therapy start and stop dates: start date: (b)(6) 2022.Stop date: (b)(6) 2022.
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