FDA-Device2024-08-21Class II
BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
Becton Dickinson & Co.
Hazard
There is a potential risk that the image colony count does not adequately reflect the actual plate colony count and may lead to inaccurate counts that would impact patient diagnosis and subsequent care.
Sold states
US distribution to states of: CO, CT, IA, IL, KY, MD, MI, MN, NC, NJ, NY, OH, OK, SC, TN, TX and WA.
Affected count
23 units
Manufactured in
7 Loveton Cir, Sparks, MD, United States
Products
BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2585-2024Don't want to check this manually?
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