E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
FDA Device Recall #Z-0564-2022 — Class I — January 27, 2022
Recall Summary
| Recall Number | Z-0564-2022 |
| Classification | Class I — Serious risk |
| Date Initiated | January 27, 2022 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | E25Bio, Inc. |
| Location | Cambridge, MA |
| Product Type | Devices |
| Quantity | 73,300 units |
Product Description
E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
Reason for Recall
The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purposes. It was distributed without sufficient directions or controls in place.
Distribution Pattern
US Nationwide distribution in the states of MA, FL, and HI.
Lot / Code Information
Lot numbers are unavailable. The following Purchase Orders and Dates are affected: Purchase Order/Invoice Number Date 1006 10/13/2020 1007 11/13/2020 1008 11/25/2020 1009 12/18/2020 1010 01/07/2021 1011 01/07/2021 1012 01/07/2021 1011 01/07/2021 1015 1/29/2021 1016 02/03/2021 1019 2/26/2021 1017 2/23/2021 1021 3/05/2021 1023 3/19/2021 1027 04/05/2021 1039 11/03/2021 1040 11/03/2021 1028 4/16/2021 1029 5/10/2021 1032 09/03/2021 1073 11/27/2020
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.