NYSDA Publications

FDA Announces Recall of Three Lots of Detect COVID-19 Tests

Per the notice below, the United States Food and Drug Administration (FDA) has announced a recall of three lots of novel coronavirus (COVID-19) tests manufactured by Detect.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: Three Detect Covid-19 Test Lots by Detect: Recall - Due to Increased Chance that Tests May Give False Negative Results

AUDIENCE: Consumer, Patient, Health Professional, Laboratory

ISSUE: Detect is recalling three specific lots, HB264, HY263, HY264, of the Detect Covid-19 Test, because there is an increased chance that the tests may give false negative results.  Detect has conducted a thorough investigation to identify this issue and has made the decision to conduct a voluntary recall for these lots.  The recall affects a total of 11,102 tests shipped to customers from July 26, 2022, through August 26, 2022.  To date, Detect has not received any reports of false negative results related to the affected lots and is issuing this recall out of an abundance of caution.  The reliability of positive test results is not affected.  The lot number can be found on the side of each test box along with the Use By date.  For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: Detect Covid-19 Test, is a molecular, over-the-counter test used to identify SARS-CoV-2 (the virus that causes Covid-19) in self-collected nasal swabs.


  • Anyone in possession of any unused tests from the affected lots should dispose of the tests.
    • Detect will issue a refund for the affected tests (as verified by Detect) upon customers' acknowledgement of receipt of the recall-related communication and confirmation that any affected tests in possession have been disposed of.  Detect Hubs, unrecalled tests, and shipping charges are not eligible for a refund.
    • Test users who attempt to use recalled tests will be notified in the Detect App that the test has been recalled and may not be used.
    • The outer packaging is recyclable while all the test components can be discarded as regular trash.
    • Detect Hubs are not affected by the recall and do not need to be discarded.
  • Contact the company's customer support team for questions and further assistance.


Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online.
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.


Read Recall Button