FDA-Device2022-05-11Class II

BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10

Becton Dickinson & Co.
Hazard

When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes.

Sold states
Worldwide distribution US Nationwide distribution in the states of CA, IL, MI, NY, OH, SC, and TN. The countries of Austria, France, Germany, Netherlands, Sweden.
Affected count
15 systems
Manufactured in
7 Loveton Cir, N/A, Sparks, MD, United States
Products
BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1018-2022

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