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Terminated

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 Recall Z-1051-2019 · Posted None

Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeJQP
Date Initiated2019-02-21
Date Terminated2020-04-17
Product Quantity5 sites

Reason for Recall

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

Firm Action

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.

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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