EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjuncti...
FDA Device Recall #Z-1414-2017 — Class II — August 25, 2014
Recall Summary
| Recall Number | Z-1414-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 25, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Becton Dickinson & Co. |
| Location | Sparks, MD |
| Product Type | Devices |
| Quantity | Qty Distr. to Field - 115 |
Product Description
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 that can manipulate and/or act upon AST results.
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.
Distribution Pattern
15 US customers, 18 Ex-US sites, and 0 distributors. Approximately 115 customers totally and 0 distributors
Lot / Code Information
Lot Numbers Version 6.20A Cat. Number 442953
Other Recalls from Becton Dickinson & Co.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0484-2026 | Class II | BD Kiestra" Isolate Suspension Cuvette Array; ... | Oct 23, 2025 |
| Z-0235-2026 | Class II | BD EpiCenter Microbiology Data Management Syste... | Sep 23, 2025 |
| Z-0236-2026 | Class II | BD BACTEC Blood Culture System, labeled as the ... | Sep 23, 2025 |
| Z-0240-2026 | Class II | BD Veritor Connect Software, labeled as the fol... | Sep 23, 2025 |
| Z-0237-2026 | Class II | BD BACTEC Blood Culture System, labeled as the ... | Sep 23, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.