Recall Z-1051-2019— Becton Dickinson & Co.
Class II · Terminated
Class II FDA medical device recall by Becton Dickinson & Co., initiated 2019-02-21, terminated 2020-04-17. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record..
- Recalling firm
- Becton Dickinson & Co.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-02-21
- Terminated
- 2020-04-17
- Firm location
- Sparks, MD, United States
Product 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.
Reason for recall
BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.
Data sourced from openFDA. This site is unofficial and independent of the FDA.