Lower riskMedical device recall · FDA · Published September 12, 2024
BD Synapsys Software Versions 4.20-5.30 May Cause False Antibiotic Results
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. Read more at govinfonow.com/recall/54034-bd-synapsys-software-versions-4-20-5-30-may-cause.
“BD Synapsys Software Versions 4.20-5.30 May Cause False Antibiotic Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54034-bd-synapsys-software-versions-4-20-5-30-may-cause. Based on FDA recall #Z-0026-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0026-2025%22&limit=1).
The FDA announced on Sept. 12, 2024, that Becton Dickinson & Co. is recalling BD Synapsys Informatics Solution software versions 4.20, 4.30, 5.10, 5.20 and 5.30 due to a hazard involving incorrect breakpoint displays for organisms without defined breakpoints in CLSI or EUCAST guidelines.
How to tell if you have it
Brand: Becton Dickinson
Product: BD Synapsys Informatics Solution
Software versions: 4.20, 4.30, 5.10, 5.20 and 5.30
Catalog Number: 444150
UDI-DI: 00382904441500
Units affected: 162
The hazard
The software error occurs when the identified organism is included in the same interpretive group as a species for which there is a specific breakpoint, potentially resulting 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.
Context
GovInfoNow's records show Becton Dickinson & Co. has 43 other recalls on record since June 1, 2017. Other recent recalls of similar products include BD GasP: CO2 Pouch System Recall (April 7, 2026), BD Kiestra Isolate Suspension Cuvette Array (Oct. 23, 2025) and Product Catalog recall (Sept. 23, 2025). Other recent recalls of similar products include Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 (June 26, 2026), Biomerieux VITEK 2 Gram-negative Susceptibility Cards (Jan. 5, 2026) and HardyDisk AST Cefiderocol 30μg FDC30 (June 8, 2026).
How to tell if you have this one
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.
Brand
Becton Dickinson
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Identify your BD Synapsys Informatics software version to see if it is 4.20, 4.30, 5.10, 5.20, or 5.30.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 34 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0026-2025 (September 12, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0026-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.