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.
What this means for you
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.
- Hazard
- software-defect
- data-integrity
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
Distributed nationwide across the United States.
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