FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: 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.
- Recall number
- Z-1051-2019
- 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.
- Status
- Terminated
- Initiated
- 2019-02-21
- Posted
- not on file
- Terminated
- 2020-04-17
- Reason
- BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.
- 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
- 5 sites
- Distribution
- Worldwide Distribution - US: Nationwide in the states of OH, IL, MO, TN and the countries of Netherlands
- Lot, serial or model codes
- BD Synapsys version 2.1 UDI: 00382904441500
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 1119779
- Firm city
- Sparks
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28