Recall Z-1414-2017 ยท JQP Calculator/Data Processing Module, For Clinical Use
Becton Dickinson & Co.
EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System . Product Usage: The EpiCenter system is a clinical data management system designed for use with certain BD instrument systems. The EpiCenter system provides advanced capabilities in data management, including extended demographic data, comprehensive reporting feature
| Date | Feb 27, 2017 (initiated Aug 25, 2014) |
| Status | Terminated |
| Reason | The information in the EpiCenter interface translation tables was not updated to match the Bruker MALDI BioTyper database identifications for some organisms. This could lead to a possible mis-identification of an organism. |
| Root cause | Vendor change control |
| Action | Customers were initially contacted via phone calls and subsequently provided with a written communication. For questions contact BD Technical Services Department at 1-800-638-8663. |
| Quantity | Qty Distr. to Field - 115 |
| Distribution | 15 US customers, 18 Ex-US sites, and 0 distributors. Approximately 115 customers totally and 0 distributors |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.