Medical Device Software Update Overwrites Custom Antibiotic Codes
BD Synapsys Microbiology Informatics Software version 4.10 overwrites customer-configured antibiotic codes with BD defaults during system updates, affecting data integrity in clinical microbiology reporting.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall affecting a medical device software system used in clinical microbiology. The defect causes loss of custom configuration data, which could affect antibiotic susceptibility reporting. No illnesses or injuries have been reported, meeting the criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10, has been recalled. The recall affects systems that are updated from BD Kiestra to this version. During the update process, any custom antibiotic codes that were configured in the system are overwritten with BD's default antibiotic codes.
The 15 affected systems are distributed in the United States across California, Illinois, Michigan, New York, Ohio, South Carolina, and Tennessee. Internationally, affected systems are located in Austria, France, Germany, Netherlands, and Sweden. The affected systems are identified by software version 4.10 and the following serial numbers: SL00530, SL00515, SL00527, SL00502, SL00540, SL00564, SL00549, SL00509, SL00003, SL00004, SL00010, SL00001, SL00005, SL00002, SL000015, SL01010, and SL01022.
Users of affected systems should contact Becton Dickinson & Co., the manufacturer, for instructions regarding this recall.
The recalled product
- Product
- BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All systems running BD Synapsys version 4.10
- UDI: 00382904441500
Distribution
Related recalls
Same manufacturer · Becton Dickinson & Co.
See all →- HighBD Phoenix Panel NMIC-312 recalled for classification error
FDA (Devices) · 2026-10-21
- SevereBD Phoenix Panel NMIC-306 Recalled for Quality Control Failures
FDA (Devices) · 2026-10-21
- ModerateBD GasPak EZ CO2 Pouch System gas generating sachets underperforming
FDA (Devices) · 2026-05-06
- ModerateBD GasPak EZ Campy Pouch System Recall for Below-Specification Gas Production
FDA (Devices) · 2026-05-06
- ModerateLaboratory cuvette arrays recalled over barcodes the analyser cannot read
FDA (Devices) · 2025-11-19
Same hazard · software defect
See all →- SeverePhilips Lumify Diagnostic Ultrasound System Recalled for Connection Issues
FDA (Devices) · 2026-10-28
- SevereMedtronic MiniMed Go App Recall for Insulin Dose Reminder Failure
FDA (Devices) · 2026-10-28
- ModerateIntelerad IntelePACS Software Recalled for Image Display Mismatch
FDA (Devices) · 2026-10-21
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
Similar recalls
- HighBD Synapsys Laboratory Software May Display Incorrect Antibiotic Susceptibility Results
FDA (Devices) · 2024-10-16
- HighBD Synapsys Laboratory Software Recalled for Incorrect Test Order Association
FDA (Devices) · 2019-04-03
- ModerateBD Synapsys Laboratory Informatics System Recalled for Service Credential Compromise
FDA (Devices) · 2024-12-11
- HighMedical Device Recall: BD Kiestra Urine Culture Software May Cause Inaccurate Results
FDA (Devices) · 2024-08-21
- HighBD Synapsys Informatics Solution risks patient data mis-association
FDA (Devices) · 2023-07-12
- HighBD Kiestra InoqulA+ Software Version 20.3 Recalled for Specimen Mismatch Risk
FDA (Devices) · 2019-09-11