November 12, Lauren Dempsey, MS in Biomedicine and Law, RN, FISM News This week the FDA recalled at-home rapid antigen COVID-19 test kits manufactured by Ellume. It is estimated that over 2 million test kits are a part of the recall due to inaccurate test results, which could result in a delay of care or incorrect treatment of patients.

The Food and Drug Administration announced a Class 1 recall of the E25Bio COVID-19 Direct Antigen Response Test. E25Bio is recalling its 

20/08/  · But in its recall announcement, the FDA described Innova’s recall of its SARS-CoV-2 Antigen Rapid Test as a “ Class 1 recall ” and gave the stern warning, “Use of these devices may cause serious injuries or death.”,

01/12/  · Recall Status 1: Open 3, Classified: Recall Number: Z-0558-2022: Recall Event ID: 89455: Product Classification: Coronavirus antigen detection test system. - Product Code QKP: Product: Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per

01/12/  · Recall Status 1: Open 3, Classified: Recall Number: Z-0558-2022: Recall Event ID: 89455: Product Classification: Coronavirus antigen detection test system. - Product Code

Empowered Diagnostics is recalling the CovClear COVID-19 Rapid Antigen Test and the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test, 

By Jenni Fink On 2/9/22 at 10:47 AM EST U.S. Coronavirus FDA Omicron The Food and Drug Administration ( FDA) announced a recall of the STANDARD Q COVID-19 Ag Home Test because of its illegal

The Food and Drug Administration (FDA) has expanded its recall of Ellume at-home COVID-19 tests due to potential false-positive results. More than 2 million tests made by the company that were

28/01/2022 · Empowered Diagnostics is recalling the CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. These tests were distributed

On June 6, , the FDA published a Class 1 medical device recall for the Innova SARS-CoV-2 Antigen Rapid Qualitative Test, which produces a 

10/06/  · Innova Medical Group Recalls Unauthorized SARS-CoV-2 Antigen Rapid Qualitative Test with Risk of False Test Results, The FDA has identified this as a Class I recall,