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Health Canada Medical devices

BD Synapsys™ Informatics Solution

Issued September 26, 2024
Issue
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
Hazard description
Performance
Product
Product name
BD Synapsys™ Informatics Solution
Reference
ID
RA-76206