4 rapid COVID-19 test recalls announced by FDA this week

The FDA recently posted recall notices for four rapid COVID-19 tests recalled since Jan. 13.

The recalls were classified as class I recalls, the most serious type.

Here are the four recalls, starting with the most recent: 

1. Celltrion USA recalled 45,500 units of its DiaTrust COVID-19 Ag Rapid Tests on Feb. 28 due to high numbers of false positive reports.

2. SD Biosensor recalled up to 397,000 units of the Standard Q COVID-19 Ag Home Test on Jan. 31. The test is not authorized, cleared, or approved by the FDA for marketing or distribution in the U.S.  

3. E25Bio recalled 73,300 units of its COVID-19 Direct Antigen Rapid Test on Jan. 27. The test is not authorized, cleared, or approved by the FDA for marketing or distribution in the U.S.  

4. LuSys Laboratories recalled 164,250 units of its COVID-19 antigen tests on Jan. 13 due to lack of emergency use authorization. The manufacturer also did not provide appropriate validation data to show that the tests can perform accurately. 

 

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