CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualita...
FDA Device Recall #Z-2407-2021 — Class II — July 27, 2021
Recall Summary
| Recall Number | Z-2407-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 27, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Versea Diagnostics LLC |
| Location | Tampa, FL |
| Product Type | Devices |
| Quantity | 563,290 in total |
Product Description
CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. (CLIA Waived Laboratories)
Reason for Recall
Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.
Distribution Pattern
US Nationwide Distribution: AL, AZ, CA, CO, CT, FL, GA, IL, KS, OH, OK, MA, MD, MI, NC, NJ, NY, PA, SC, TX, VA, and WA.
Lot / Code Information
all lot codes
Other Recalls from Versea Diagnostics LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2408-2021 | Class II | FaStep COVID-19 IgG/IgM Rapid Test Device Qual... | Jul 27, 2021 |
| Z-2410-2021 | Class II | Status COVID-19/Flu Rapid Immunoassay for Direc... | Jul 27, 2021 |
| Z-2409-2021 | Class II | Healgen COVID-19 IgG/IgM Rapid Test Cassette (W... | Jul 27, 2021 |
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.