Recall Z-1051-2019 ยท JQP Calculator/Data Processing Module, For Clinical Use
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, eval
| Date | Feb 21, 2019 |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.