Becton Dickinson & Co. recalls BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution pro…

Recall date

February 21, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1051-2019

FDA classification

Class II

Brand / firm

Becton Dickinson & Co.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.