18/02/2022 · FDA alerts providers to COVID-19 rapid test recall, Feb 18, 2022 - 11:10 AM, The Food and Drug Administration today announced a Class 1 recall of the E25Bio COVID-19 Direct Antigen Response Test, which was marketed and distributed to U.S. customers without authorization or approval.

09/02/2022 · In a January 9 press release, ACON Laboratories revealed they had issued a recall of the Flow flex SARS-CoV-2 Antigen Rapid Test (Self-Testing), which had been distributed throughout the US,

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.

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

Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Labeled for Research Use Only The FDA has identified this as a Class I recall, the most serious type of recall. Use

29/07/  · The FDA states the reasons for the COVID test recall: “Innova Medical Group is recalling its SARS-CoV-2 Antigen Rapid Qualitative Test. Labeling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during the clinical studies of the tests.

North American Diagnostics Recalls Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits That Are Not Authorized, Cleared, or Approved by the FDA. 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.

21/03/2022 · FDA issued two Class 1 Device Recalls, the most serious type of recall, for the Celltrion DiaTrust™ COVID-19 Ag Rapid Test, Reference Number CT-P60 D-2 02. FDA initially authorized this test on April 16, for use at the point-of-care (POC) such as health clinics and congregate settings.

02/03/  · On 03/02/ , the firm sent an "URGENT: Medical Device Recall" Notification Letter via email or mail to customers informing them that Rapid Test kits were incorrectly labeled as "for diagnostic use" and labeled with an unsupported expiration date. Between 03/22-26/ , the firm sent a revised/follow-up Recall Notification Letter via email. Customers are instructed

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

25/07/  · 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