Company: Becton Dickinson & Co.
Date of Enforcement Report: 4/3/2019
Class II:
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.
Recall Number: Z-1051-2019
REASON
BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Co. on 2/21/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
5 sites
DISTRIBUTION
US Nationwide and International