Product Wiki · Recalls · Health Canada — Medical Devices

cobas IT middleware (2019-06-12) — recall 59498

Health Canada — Medical Devices · Canada · 2019-06-28 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
59498
Date of alert
2019-06-28
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: The cobas IT middleware of software version 1.10.00 using the multi-level QC configuration may allow patient results to be released with invalid QC results. This affect the evaluation of the QC lock-status (QC error) when more than one level is configured to be used.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cobas-it-middleware-2019-06-12

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