Becton Dickinson recalls Synapsys Informatics software versions 4.20, 4.30, 5.10, 5.20, and 5.30 for IVD labs. These versions may show incorrect antibiotic susceptibility results, risking ineffective treatment or prolonged therapy.
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
Becton Dickinson is recalling specific software versions of their Synapsys Informatics lab system. These versions can display false antibiotic susceptibility results, which might lead to ineffective treatment or longer antibiotic use.
The software incorrectly displays breakpoints for organisms without defined breakpoints in standard antibiotic guidelines. This can cause false susceptible or false resistant results, potentially leading to ineffective antibiotic treatment or prolonged therapy.
Laboratories using BD Synapsys Informatics software versions 4.20, 4.30, 5.10, 5.20, or 5.30 are affected. Lab staff and patients using these versions may face incorrect antibiotic treatment decisions.
Check if your lab uses BD Synapsys Informatics software with versions 4.20, 4.30, 5.10, 5.20, or 5.30. The catalog number is 444150, and the UDI-DI is 00382904441500.
Identify your BD Synapsys Informatics software version to see if it is 4.20, 4.30, 5.10, 5.20, or 5.30.
Software versions 4.20, 4.30, 5.10, 5.20, and 5.30 of BD Synapsys Informatics.
False susceptible results may lead to ineffective antibiotic treatment, while false resistant results could prolong therapy with less effective antibiotics.
The recall record does not mention a remedy or fix.
We’ve drafted a message you can send Becton Dickinson to request your refund or repair — edit it as you like.
Subject: Recall Z-0026-2025 — Becton Dickinson Becton Dickinson Hello, I own a Becton Dickinson that is covered by recall Z-0026-2025 from Becton Dickinson. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
