NYSDA Publications

FDA Announces Recall of Two COVID-19 Tests

The United States Food and Drug Administration (FDA) has announced a recall of two tests for the novel coronavirus (COVID-19): 1) Woodside Acquisitions Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; and 2) Joysbio SARS-CoV-2 Antigen Rapid Test Kit [Colloidal Gold].  FDA notes that these tests are being recalled because they were distributed to customers without authorization, clearance, or approval from the FDA and that the FDA was not provided with adequate validation data to show that the performance of these tests is accurate -- and there is a risk of potential false negative, false positive, or misinterpretation of results.  To read the FDA announcement and summary of the recall of two COVID-19 tests, use the link below.
https://www.fda.gov/medical-devices/medical-device-recalls/woodside-acquisitions-inc-recalls-oral-rapid-sars-cov-2-antigen-rapid-test-kits-and-joysbio-sars-cov?utm_medium=email&utm_source=govdelivery
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