Becton Dickinson & Co. Recall: EpiCenter Plus Microbiology Data Management System software
Becton Dickinson & Co. Recall: EpiCenter Plus Microbiology Data Management System software is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Becton Dickinson & Co.; Product: EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI
| Recalling firm | Becton Dickinson & Co. |
|---|---|
| Product | 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 features including a powerful database query tool, bi-directional Laboratory Information System (LIS) communications and long-term data storage. Additionally, the EpiCenter system provides an Expert System th |
| Reason for recall | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | 15 US customers, 18 Ex-US sites, and 0 distributors. Approximately 115 customers totally and 0 distributors |
| Recall initiated | 20140825 |
| Recall number | Z-1414-2017 |
| Category | device |
| State | MD |
| Country | United States |
$29/mo
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