Product Wiki · Recalls · Health Canada — Medical Devices

Stratus CS 200 Acute Care Diagnostics System (2019-03-19) — recall 59419

Health Canada — Medical Devices · Canada · 2019-04-29 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
59419
Date of alert
2019-04-29
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: While using a POCT-1A communication protocol, the following error codes will not be sent from the Stratus CS 200 to the LIS. - CH1H - CH1L - CH1M - CH1N - CH2H - CH3H - CS1K - CS1V The error messages will show on the instrument display and printout with the exception of CS1v. CS1V will only be displayed on the instrument as it indicates communication with the lis is not working. The other communication protocols are not affected by this issue.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/stratus-cs-200-acute-care-diag

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