The U.S. Food and Drug Administration has recalled E25Bio rapid COVID-19 tests because the tests were not approved by the agency, 

test kits with the trade name “Flowflex SARS-CoV-2 Antigen Rapid Test. (Self-Testing),” and subsequently issued a recall as these tests have 

North American Diagnostics has recalled over 122,000 oral rapid COVID-19 antigen test kits because the 

29/07/  · 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 result faster than a PCR test that must be analyzed in

A week after the FDA urged anyone who had Innova Medical Group's COVID-19 antigen test to stop using it and toss it in the trash, regulators across the pond 

This press release serves as public announcement that this CE marked product is being recalled from the U.S. market. The " Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)" cannot be legally

26/07/  · Below you can read the information that FDA.gov shared about the recall. 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, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product,

10/06/  · On April 23, , Innova Medical Group recalled their Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test. The FDA has identified this recall as a Class I recall,

Dive Brief: The Food and Drug Administration labeled another COVID-19 rapid antigen test as a Class I event, assigning the highest risk category to SML Distribution's withdrawal of 209,450 unauthorized products. SML began contacting its customers by phone in March and went on to email a recall notice later that month.

According to the FDA, the company did not provide the agency with adequate validation data to prove the test's performance is accurate, meaning 

On April 23, , Innova Medical Group recalled their Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test. The FDA has identified this recall as a Class I recall, the most serious type

Empowered Diagnostics is recalling the CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. These tests were distributed with labeling indicating they are

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

25/07/  · The Innova SARS-CoV-2 Antigen Rapid Qualitative Test, the CDC’s benchmark COVID diagnostic testing system, will be withdrawn for Emergency Use by the end of due to an inordinate frequency of false positive and negative results. “The FDA has identified this as a Class I recall, the most serious type of recall.

WWTI) — The Food and Drug Administration has issued a recall on the “Flowflex™ SARS-CoV-2 Antigen Rapid Test.” According to the FDA, 

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

June 9, 2022, Update: The FDA updated this recall classification notice to remove Woodside Acquisitions Inc from the device use section of the notice. This firm's name does not appe the label for the Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit and the Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) and to clarify that these tests were not authorized, cleared, or approved by

Innova Medical Group is recalling its SARS-CoV-2 Antigen Rapid Qualitative Test. The test kit was recalled because performance claims "did not accurately reflect the performance estimates observed during the clinical studies of the tests." The test kit also presents risk of showing false positives as well as false negatives.

25/02/2022 · Class 2 Device Recall Celltrion DiaTrustTM COVID19 Ag Rapid Test: Date Initiated by Firm: February 25, 2022: Create Date: March 08, 2022: Recall Status 1: Open 3, Classified: Recall Number: Z-0731-2022: Recall Event ID: 89640 : Product Classification: Coronavirus antigen detection test system. - Product Code QKP: Product: Celltrion DiaTrust COVID-19 Ag

FDA Recalls 200,000 Unauthorized Flowflex COVID Rapid Tests It's estimated that over 200,000 units of the at-home test have been in U.S. circulation By Brian Price • Published January 14, 2022 •

The FDA has issued a Class I recall warning the public to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use.