ProductGuru Recalls

Official recall record

BD Synapsys™ Informatics Solution

Health Canada — Medical Devices · 2024-09-26 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2024-09-26
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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