Health Canada — Medical Devices · Canada · 2022-09-23 · Type II
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Reported risk: The Alinity h-series system control center (SCC) application software version 4.3 (and below) and the local user interface (LUI) embedded analyzer engine (EAE) contain a cybersecurity certificate that expired on 08sep2022. Whenever the software checks for the cybersecurity certificate expiration date and it detects that it has expired, the SCC and/or LUI becomes nonfunctional. This renders the Alinity h-series unable to process samples. There is no impact to cybersecurity or results integrity on the Alinity h-series with this issue. Recall start date: September 12, 2022
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