Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatograp...
FDA Device Recall #Z-2808-2020 — Class II — June 18, 2020
Recall Summary
| Recall Number | Z-2808-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 18, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Chembio Diagnostics, Inc |
| Location | Medford, NY |
| Product Type | Devices |
| Quantity | 126 kits |
Product Description
Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood, serum, or plasma (lithium heparin or EDTA. Model Number: 70-1069-0
Reason for Recall
FDA revocation of the Emergency Use Authorization due to performance issues
Distribution Pattern
Nationwide
Lot / Code Information
Lot Numbers: 83716171 83720151 83720153
Other Recalls from Chembio Diagnostics, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2807-2020 | Class II | Chembio DPP COVID-19 IgM/IgG System- Rrapid imm... | Jun 18, 2020 |
| Z-2809-2020 | Class II | Chembio DPP¿ Micro Reader II for use with the D... | Jun 18, 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.