FDA Advisory No.2021-2454 || Caution on the purchase and use of certain COVID-19 Test Kits following the performance validation conducted by the RITM
In the interest of protecting public health and safety, the Food and Drug Administration (FDA) hereby provides the lists of companies with issued Special Certificate and failed performance validation conducted […]
FDA Advisory No.2021- 2366 || Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit “CIRCLE HEALTH POD SET”
The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the uncertified Covid-19 test kit: 1. CIRCLE HEALTH POD SET The […]
FDA Advisory No.2021-2381 || Public Health Warning Against the Illicit Online Selling of Medicines used for treatment of COVID-19
The Food and Drug Administration (FDA) warns all healthcare professionals and the public on significant risks associated with the growing internet sales of medicines. The recent surge of COVID-19 infections […]
FDA Advisory No.2021-2380 || Public Health Warning Against the Purchase of COVID-19 Vaccines from Online Selling Platforms and Social Media Market Places
According to the Interpol “You cannot find legitimate, approved COVID-19 vaccines for sale on the internet; legitimate vaccines are not for sale, they are strictly administered and distributed by national […]
FDA Advisory No.2021-1124A || Completion of the Voluntary Recall of Covidien Surgiwand™ II Suction and Irrigation Devices
This is to inform all concerned healthcare professionals and establishments that the Voluntary Recall of affected lots/batches of Covidien Surgiwand™ II Suction and Irrigation Devices, manufactured by Covidien-USA and imported […]
FDA Advisory No.2021-2095 || Voluntary Recall of Covidien DAR™ Airway Products
The Food and Drug Administration (FDA) warns all healthcare professionals and establishments on the voluntary recall of affected lots of Covidien DAR™ Airway Products manufactured by Covidien-USA, imported and distributed […]
FDA Advisory No.2021-2094 || List of COVID-19 Test Kits with FDA Special Certification and Performance Validation Conducted and/or Recommended by the Research Institute for Tropical Medicine (RITM)
On 23 March 2021, the Food and Drug Administration (FDA) issued FDA Memorandum No. 2021-009 entitled “Minimum Performance Requirements for COVID-19 Test Kits Used for SARS-CoV-2 Infection”. This issuance provides […]
FDA Advisory No.2021-1896 || Recall of COVID-19 Test Kits with Low Results of Performance Validation Conducted by the Research Institute of Tropical Medicine (RITM)
The Food and Drug Administration (FDA) informs all concerned healthcare professionals and the general public on the recall of the following COVID-19 test kits distributed by the corresponding Market Authorization […]
FDA Advisory No.2021-1684 || Caution on the purchase and use of certain COVID-19 Test Kits following the performance validation conducted by the RITM
The Food and Drug Administration (FDA) informs all healthcare professionals and the general public that the following COVID-19 test kits distributed by the corresponding Market Authorization Holders (MAH) did not […]
FDA Advisory No.2021-1385 || Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit “WONDFO – 2019-N-COV ANTIGEN TEST (LATERAL FLOW METHOD)”
The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the uncertified Covid-19 test kit: The FDA verified through post-marketing […]