Device product
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.
Z-1051-2019
Product summary
- Event
- Event 82225
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 sites
- Official record key
device-enforcement:Z-1051-2019
Official wording
Reason: BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.
Code information: BD Synapsys version 2.1 UDI: 00382904441500
Distribution pattern: Worldwide Distribution - US: Nationwide in the states of OH, IL, MO, TN and the countries of Netherlands
Derived failure modes
-
Unknown
BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.