FDA-Device2019-04-03Class II
BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical diagnostic activities. The software integrates operational and clinical data points from laboratory hardware, with patient data received from external software systems allowing for the aggregation, evaluation, dissemination of knowledge using all data, anywhere, anytime. Currently Release 2 of BD
Becton Dickinson & Co.
Hazard
BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.
Sold states
Worldwide Distribution - US: Nationwide in the states of OH, IL, MO, TN and the countries of Netherlands
Affected count
5 sites
Manufactured in
7 Loveton Cir, N/A, Sparks, MD, United States
Products
BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical diagnostic activities. The software integrates operational and clinical data points from laboratory hardware, with patient data received from external software systems allowing for the aggregation, evaluation, dissemination of knowledge using all data, anywhere, anytime. Currently Release 2 of BD Synapsys can connect to both Lab Automation (Kiestra) and BACTEC instruments.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1051-2019Don't want to check this manually?
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