Extended Expiration Dates: BinaxNOW, MaximBio ClearDetect, and iHealth COVID-19 Tests

U.S. Food and Drug Administration sent this bulletin at 01/19/2023 11:21 AM EST

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Center for Devices and Radiological Health

Update: Extended Expiration Dates for BinaxNOW, MaximBio ClearDetect, and iHealth COVID-19 Tests

BinaxNow, iHealth, Clear Detect COVID-19 tests extended expiration

Abbott Diagnostics Scarborough BinaxNOW COVID-19 Antigen Self Tests, Maxim Biomedical MaximBio ClearDetect COVID-19 Antigen Home Tests, and iHealth Labs iHealth COVID-19 Antigen Rapid Tests that are FDA authorized under emergency use authorization now have a longer shelf-life than previously authorized.

The expiration dates for these tests have been extended to reflect the longer shelf-life. The extension is based on additional data provided by the manufacturer showing how long the test can be used with the same expected accuracy.

Check whether your BinaxNOW COVID-19 Antigen Self Test, MaximBio ClearDetect COVID-19 Antigen Home Test, iHealth COVID-19 Antigen Rapid Test, or another test that you have has a new expiration date.

Check Expiration Dates

Visit At-Home OTC COVID-19 Diagnostic Tests and At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions for more information.

Questions?

If you have questions about this update, contact the Division of Industry and Consumer Education.

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