Product Wiki · Recalls · Health Canada — Medical Devices

BD Synapsys™ Informatics Solution — recall 76206

Health Canada — Medical Devices · Canada · 2024-09-26 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
76206
Date of alert
2024-09-26
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
General hospital and personal use
Product type
Medical devices
Reported risk: BD identified through one (1) complaint that for BD Kiestra™ customers with BD Synapsys™, running Synapsys™ software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys™ will incorrectly display breakpoints for organisms that do not have defined breakpoints in CLSI or EUCAST. This occurs when the identified organism is included in the same interpretive group as a species for which there is a specific breakpoint. Recall start date: September 12, 2024
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/bd-synapsystm-informatics-solu

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