Sensor 3mh002hv3fm has been returned and investigated.Visual inspection has been performed and no issues were observed.Extended investigation has also been performed.Dhrs for the fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor kit and sensor kit passed all tests prior to release.Dose audit reports were reviewed and demonstrates the continued effectiveness of the established sterilization process for libre sensor products.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.
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