BD Synapsys Laboratory Solutions recallZ-1051-2019 · Becton Dickinson & Co. · initiated Feb 21, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton Dickinson & Co. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-1051-2019
- Status
- Terminated
- Initiated by the company
- Feb 21, 2019
- Recalling firm
- Becton Dickinson & Co.
- Quantity
- 5 sites
- Product code
- JQP
- Distribution
- Worldwide Distribution - US: Nationwide in the states of OH, IL, MO, TN and the countries of Netherlands
Product description
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.
Code information (models, lots, serial numbers)
BD Synapsys version 2.1 UDI: 00382904441500
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BD Synapsys™ Informatics Solution 444150Becton, Dickinson And Company · Calculator/data processing module, for clinical use5 recalls81 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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