Recall Z-1018-2022 ยท JQP Calculator/Data Processing Module, For Clinical Use
Becton Dickinson & Co.
BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
| Date | Mar 9, 2022 |
| Status | Terminated |
| Reason | When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes. |
| Root cause | Under Investigation by firm |
| Action | A MEDICAL DEVICE CORRECTION notification letter dated 3/9/22 was distributed to customers. PLEASE TAKE THE FOLLOWING ACTIONS: 1. Ensure the contents of this notification are read and understood by those within your organization. 2. BD will be contacting you within one week to request remote access to your database to confirm your configuration and evaluate potential impact. If BD determines that your facility has an affected configuration, BD will work with your facility to resolve the issue. In the interim, you many continue use of the product until BD contacts your facility. 3. Complete the |
| Quantity | 15 systems |
| Distribution | Worldwide distribution US Nationwide distribution in the states of CA, IL, MI, NY, OH, SC, and TN. The countries of Austria, France, Germany, Netherlands, Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.