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Becton Dickinson & Co. recalls BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory sof

Recalled October 16, 2024 · FDA recall Z-0026-2025 · Becton Dickinson &

Hazard
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. May result in either a false susceptible or false resistant result. A false susceptible result can cause inadequate or incomplete antibiotic treatment due to the use of an ineffective antibiotic, and a false resistant result may limit access to a preferred antibiotic regimen with possible elongation of therapy · FDA Class II
Units
162 units
Sold at
Nationwide Foreign: Australia, New Zealand, Singapore, Hong Kong, Taiwan, Japan, Austria, Belgium, Denmark, France, Germany, Italy, Luxembourg, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom, Russia, Saudi Arabia, South Africa, Canada, Mexico, China

Description

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. May result in either a false susceptible or false resistant result. A false susceptible result can cause inadequate or incomplete antibiotic treatment due to the use of an ineffective antibiotic, and a false resistant result may limit access to a preferred antibiotic regimen with possible elongation of therapy

Product
BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150
Manufacturer(s)
Becton Dickinson & Co.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Becton Dickinson & Co. recalls BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory sof | RecallWatchUSA