FDA-Device2023-07-12Class II
BD Synapsys Informatics Solution, Catalog Number 444150
Becton Dickinson & Co.
Hazard
There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) is operating near capacity and are using save actions (Skip, Final Discard, Mark as Read, Save) to process patient results rapidly.
Sold states
US States: CA, CO, IA, IL, MI, MN, MO, NY, OH, OK, SC, TN, TX, UT, WI. Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom
Affected count
102 systems
Manufactured in
7 Loveton Cir, N/A, Sparks, MD, United States
Products
BD Synapsys Informatics Solution, Catalog Number 444150
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2099-2023Don't want to check this manually?
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