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.
Enforcement
- Recall Number
- Z-1051-2019
- Event ID
- 82225
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Becton Dickinson & Co.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 3, 2019
- Initiation Date
- February 21, 2019
- Classification Date
- March 22, 2019
- Termination Date
- April 17, 2020
- Address
- 7 Loveton Cir, N/A, Sparks, MD, 21152-9212, United States
Description
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.
BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.
BD Synapsys version 2.1 UDI: 00382904441500
Worldwide Distribution - US: Nationwide in the states of OH, IL, MO, TN and the countries of Netherlands
5 sites