Public recall detail

BD Synapsys™ Informatics Solution

2024-09-26

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Recall Safety notice
Quick summary

Quick summary: BD Synapsys™ Informatics Solution. Date: 2024-09-26.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: BD Synapsys™ Informatics Solution. Date: 2024-09-26.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandBecton Dickinson And Company [Bd]
ProductBD Synapsys™ Informatics Solution
IssueMedical devices - Performance
Recall classType II
IdentificationRA-76206

Affected products

ProductBD Synapsys™ Informatics Solution
LotVersion # 4.20,4.30,5.10,5.20,5.30
Model444150
Serial numberVersion # 4.20,4.30,5.10,5.20,5.30
DescriptionBD Synapsys™ Informatics Solution

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General hospital and personal use
CompaniesBecton Dickinson And Company (BD) 7 Loveton Circle, Sparks, Maryland, United States, 21152
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76206
Background{}
CompaniesBecton Dickinson And Company (BD) 7 Loveton Circle, Sparks, Maryland, United States, 21152
AudiencesHealthcare
Source updated2024-09-26

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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