Product Wiki · Recalls · Health Canada — Medical Devices

EnGen Laboratory Automation System (2014-03-21) — recall 51493

Health Canada — Medical Devices · Canada · 2014-04-14 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
51493
Date of alert
2014-04-14
Country / jurisdiction
Canada
Authority classification
Type II
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Ortho Clinical Diagnostics internal testing has determined that when a sample requires follow-up action, such as dilution or retesting due to a mechanical issue, it is possible for that sample to be routed to the sample storage drawer prior to completion of the necessary pending action. A delay in patient test result(s) reporting could occur. This affects engen laboratory automation systems configured with Data Innovations, LLC Instrument Manager V8.06.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/engen-laboratory-automation-sy

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