NYSDA Publications

FDA Issues Recall of Jiangsu Well Biotech Co., Ltd., COVID-19 Ag Rapid Test Devices

The United States Food and Drug Administration (FDA) has issued a recall of the Jiangsu Well Biotech Co., Ltd., COVID-19 Ag Rapid Test Devices.  Jiangsu Well Biotech Co., Ltd., is recalling their COVID-19 Ag Rapid Test Devices because they were distributed to customers without authorization, clearance, or approval from the FDA.  FDA notes that there is a risk of potential false negative, false positive, or misinterpretation of results and that use of these tests may cause serious adverse health consequences or death.  The FDA has identified this as a Class I recall, the most serious type of recall.  To read the FDA recall of the Jiangsu Well Biotech Co., Ltd., COVID-19 Ag Rapid Test Devices, use the link below.
https://www.fda.gov/medical-devices/medical-device-recalls/jiangsu-well-biotech-co-ltd-recalls-covid-19-ag-rapid-test-devices-are-not-authorized-cleared-or?utm_medium=email&utm_source=govdelivery
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