Z-1051-2019Class II

BD Synapsys Laboratory Solutions Catalog Number:444150

Name: Z-1051-2019 BD Synapsys Laboratory Solutions Catalog Number:444150
Creator: Becton Dickinson & Co.
Published: 2019-02-21
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2019-02-21 / Terminated / root cause: software

FDA source

Becton Dickinson & Co. began a recall of BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow... on 2019-02-21. FDA classified it as Class II and gives the reason as "BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1051-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-21
Posted: 2019-03-23
Terminated: 2020-04-17
Recalling firm: Becton Dickinson & Co
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.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 5 sites
Distribution: Worldwide Distribution - US: Nationwide in the states of OH, IL, MO, TN and the countries of Netherlands
Product codes and lots: BD Synapsys version 2.1 UDI: 00382904441500

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1051-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1051-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-22

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)