FDA recall Z-1051-2019

Becton Dickinson & Co. · Class II · 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.

Reason for recall

BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.

Distribution

Worldwide Distribution - US: Nationwide in the states of OH, IL, MO, TN and the countries of Netherlands

Key facts

Status
Terminated
Initiation date
2019-02-21
Report date
2019-04-03
Termination date
2020-04-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sparks, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1051-2019