—#171162

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.

FDA product code: JQP — Calculator/Data Processing Module, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: BD Synapsys version 2.1 UDI: 00382904441500

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

BD notified Synapsys Customer via letter UPS on 02/21/19 identified problem and action taken. Customer sites were updated remotely with a database update on January 10, 2019. Accounts asked to complete and return the CUSTOMER RESPONSE FORM BD Synapsys. The issue will be resolved by the software update syngo CT VB10A_SP1 (Service Pack 1) as soon as the update is available. For questions contact BD Customer/Technical Support at 8006388663. For customers outside the US, contact your local BD representative or distributor.

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

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

Timeline

Recall initiated: 2019-02-21
Terminated: 2020-04-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171162. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.