FDA Extends Expiration Dates for OTC COVID-19 At-Home Tests: What You Need to Know
FDA Extends Expiration Dates for OTC COVID-19 At-Home Tests: What You Need to Know
Published: February 22, 2025
By Garcia Family Medicine
The U.S. Food and Drug Administration (FDA) has issued an important update regarding the Wondfo USA Co., Ltd. WELLlife COVID-19/Influenza A&B Home Test, extending the expiration dates for certain lots. This change ensures these tests remain reliable beyond their original shelf life, offering relief to households and healthcare providers alike as we navigate ongoing respiratory illness concerns.
What Happened?
The FDA, based on new stability data from Wondfo USA, has confirmed that specific lots of the WELLlife COVID-19/Influenza A&B Home Test can be used past their printed expiration dates without losing accuracy. Announced on February 22, 2025, this extension applies to tests already distributed across the U.S., giving consumers more time to use their kits effectively for detecting COVID-19 and influenza A and B.
Affected Products
This update covers the WELLlife COVID-19/Influenza A&B Home Test, an over-the-counter (OTC) product designed for at-home use with a nasal swab, delivering results in just 10 minutes. The extension applies only to certain lots—those with updated expiration dates based on manufacturer data. Not all kits are affected, so checking your specific lot is key.
The Importance of This Update
Accurate at-home testing is critical for managing respiratory illnesses like COVID-19 and flu. Extending expiration dates means fewer tests go to waste, ensuring you have a reliable tool on hand when symptoms strike. This is especially valuable during peak seasons, helping you catch infections early and reduce spread to family, friends, or coworkers.
Recommendations for Consumers
To make the most of this update:
Check Your Test: Locate the lot number on your test kit, typically near the expiration date.
Verify the Extension: Visit the FDA’s At-Home OTC COVID-19 Diagnostic Tests page or wondfousa.com to see if your lot qualifies for an extended date.
Contact Support if Needed: For clarification, reach out to Wondfo at +1 (888) 444-3657 or support@welllifebio.com.
If your test is past its original date but not on the extended list, discard it safely and replace it to ensure accurate results.
Taking Action
If you have questions about your test or need help verifying its status, contact the FDA’s Division of Industry and Consumer Education or visit their website for assistance. Staying proactive keeps your testing reliable and your health protected.
This FDA update underscores the importance of staying informed about the tools we use to safeguard our well-being. By keeping your tests up to date, you’re better equipped to handle whatever this season brings.
For more health insights and updates, check out the CDC’s COVID-19 Testing page.
Stay safe and informed,
Garcia Family Medicine Team
For any concerns or questions about this update, feel free to contact us at garciafamilymedicine.care. Your health and safety are our priority.
