Medical Device Recall: BD Kiestra Urine Culture Software May Cause Inaccurate Results
Becton Dickinson & Co. is recalling the BD Kiestra Urine Culture Application due to a software issue that may cause inaccurate bacterial colony counts. This could impact patient diagnosis and treatment decisions.
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: FDA Class II medical device with a potential diagnostic accuracy risk that could impact patient diagnosis, but no reported illnesses or injuries. The hazard is theoretical, with no confirmed harm reported, fitting the High severity category for risk-of-harm products without documented injury.
Plain-English summary
Becton Dickinson & Co. is recalling the BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution, Catalog Reference 444900. This is a laboratory medical device used in clinical diagnostics to analyze bacterial culture samples from urine.
The FDA has identified a potential risk with the device's image analysis function. The device's calculated colony count may not accurately reflect the actual number of bacterial colonies on the culture plate. These inaccuracies could result in incorrect laboratory reports that would impact patient diagnosis and subsequent medical care.
This recall involves 23 affected units distributed to clinical laboratories in 17 U.S. states: Colorado, Connecticut, Iowa, Illinois, Kentucky, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas, and Washington. Specific serial numbers are available to identify affected devices.
The recalled product
- Product
- BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 23
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 (20)
- Catalog (Ref): 444900
- UDI-DI: 00382904449001
- Serial Numbers: IA00084
- IA00054
- IA00055
- IA00088
- IA00041
- IA00071
- IA00085
- IA00007
- IA00014
- IA00005
- IA00053
- IA00073
- IA00081
- IA00011
- IA00012
- IA00027
- SL01023
- IA00026
Distribution
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