fda rapid test recall

MAUDE Adverse Event Report: IHEALTH LABS, INC. IHEALTH

Used ihealth covid 19 antigen rapid test. Retail box includes two test kits. After using one, replaced cap on the used buffer tube. New and used buffer tubes then became indistinguishable. This led to scrapping the second test kit in the box. A user not noticing the problem may discard the new buffer and re-use the used buffer leading to a wrong result on the second test. This

SML Distribution LLC Recalls Skippack Medical Lab COVID

SML Distribution LLC Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA.

North American Diagnostics Recalls SARS-CoV-2 Rapid

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

Did the FDA Recall All COVID-19 PCR Tests?

According to a Reuters Fact Check, that's not the case at all. In fact, the recall only applies to one company's PCR test, the Innova SARS-CoV-2 Antigen Rapid 

FDA warns about unauthorized versions of rapid COVID-19

Last month, Roche partner SD Biosensor announced a recall of illegally imported rapid antigen COVID-19 tests from the U.S. and said it was 

Class 1 Device Recall Celltrion DiaTrust COVID19 Ag Rapid Test

for Recall: Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID. FDA Determined Cause 2: Other: Action: On April 1, 2022, the firm notified distributors of the issue via letter, following up with meetings with each distributor on April 5, 2022 and emails on April 6, 2022.

FDA Recalls E25Bio Rapid COVID-19 Antigen Tests - WebMD

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

Innova Medical Group Recalls SARS-CoV-2 Antigen

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,

JUST-IN: Recall For COVID-19 Rapid Tests Issued By FDA!

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,

Stop Innova Medical Group SARS-CoV-2 Antigen Rapid

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,

Empowered Diagnostics Recalls COVID-19 Tests due to Risk of False

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