BD Synapsys Laboratory Software May Display Incorrect Antibiotic Susceptibility Results
BD Synapsys Informatics Solution versions 4.20–5.30 contain a software error that may incorrectly display antibiotic susceptibility results, potentially leading to inadequate or prolonged antibiotic treatment.
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: FDA Class II medical device with a software error affecting critical diagnostic data and patient treatment decisions. Fits the rubric criterion of risk-of-harm products where injury has not yet been reported. No illnesses or injuries have been documented.
Plain-English summary
BD Synapsys Informatics Solution is a laboratory software for data management and workflow management in clinical diagnostic facilities. The recall affects software versions 4.20, 4.30, 5.10, 5.20, and 5.30, with 162 units distributed nationwide and internationally.
The software contains an error in its in-line breakpoint feature. When an organism is identified that belongs to an interpretive group containing a species with defined susceptibility breakpoints, the software incorrectly displays breakpoints for organisms that have no defined breakpoints in CLSI or EUCAST standards. This can result in either a false susceptible or false resistant interpretation.
A false susceptible result can cause inadequate or incomplete antibiotic treatment due to use of an ineffective antibiotic. A false resistant result may limit access to preferred antibiotic regimens with possible elongation of therapy. The software error affects the accuracy of diagnostic information used in patient care decisions.
The recalled product
- 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
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- software-error
- false-susceptible-result
- false-resistant-result
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 (4)
- UDI-DI: 00382904441500 Software versions: 4.20
- 4.30
- 5.10
- 5.20 and 5.30
Distribution
Distributed nationwide across the United States.
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