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VITROS® Systems — recall 74504

Health Canada — Medical Devices · Canada · 2023-10-31 · Type II

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Agency: Health Canada — Medical Devices
Recall identifier: 74504
Date of alert: 2023-10-31
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: Chemistry
Product type: Medical devices

Reported risk: After the launch of software version (v) 3.8.0, Ortho Clinical Diagnostics (QuidelOrtho) began post-release monitoring of the rollout of v3.8.0. this monitoring has led QuidelOrtho to confirm that if v3.8.0 has been installed on the VITROS® systems listed above, these systems may experience an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a 'screen freeze'), and/or printer disconnections. Recall start date: October 11, 2023

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/vitrosr-systems

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VITROS® Systems — recall 74504

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