Health product recall

BD Synapsys™ Informatics Solution

Last updated

Summary

Product
BD Synapsys™ Informatics Solution
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

BD Synapsys™ Informatics Solution

Version # 4.20,4.30,5.10,5.20,5.30

444150

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Becton Dickinson And Company (BD)

7 Loveton Circle, Sparks, Maryland, United States, 21152

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76206

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