Health Canada — Medical Devices · Canada · 2018-10-05 · Type II
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Reported risk: BioFire Diagnostics, LLC has identified an increased risk of false positive proteus results when the Filmarray Blood Culture Identification (BCID) panel is used with BacT/ALERT Culture media with expiration dates of 2019-05-02 and beyond. The intended function of BacT/ALERT Blood culture bottles (culturing viable microorganisms) is not compromised by this anomaly. It is unknown if subsequent lots of media will also be subject to this risk.
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