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Bd synapsys™ informatics solution

Official notice

26 Sept 2024

Last checked

26 Sept 2024

Medium riskHealth Canada

An official Health Canada notice concerns Bd synapsys™ informatics solution. 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 Published 2024-09-26.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76206

Official notice

2024-09-26

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

76206

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Affected products

Product 1

Affected products - BD Synapsys™ Informatics Solution, Lot or serial number - Version # 4.20,4.30,5.10,5.20,5.30, Model or catalog number - 444150

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Becton Dickinson And [bd], Bd Synapsys™ Informatics Solution.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

76206

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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