COVID-19 Testing

Home Testing Recall Updates 2022 

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March 14, 2022 NJLINCS Health Alert Network, Distributed by the New Jersey Department of Health
Public Health Info - 
ACON Biotech Flowflex COVID-19 Tests: FDA Safety Communication 111248-3-14-2022-PHIN 

Eric Lieberman, (609) 826-4935, eric.lieberman@doh.nj.gov 
William Manley, (609) 826-4935, william.manley@doh.nj.gov 

 

Update: The U.S. Food and Drug Administration (FDA) updated this safety communication to clarify that the ACON Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) in dark blue packaging is a product of ACON Biotech (Hangzhou) Co., Ltd.


The FDA issued a safety communication warning people not to use the ACON Biotech test named Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing). This test is packaged in a dark blue box and has not been authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this unauthorized test.
 

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February 8, 2022  NJLINCS Health Alert Network, Distributed by the New Jersey Department of Health 
Public Health Recall – STANDARD Q COVID-19 Ag Home Test by SD BIOSENSOR: Recall - Due to Test Kits Being Illegally Imported Into The United States 
Distributed by the New Jersey Department of Health 111211-2-8-2022-RECL, Eric Lieberman, (609) 826-4935, eric.lieberman@doh.nj.gov, William Manley, (609) 826-4935, william.manley@doh.nj.gov

AUDIENCE: Consumer, Health Professional
ISSUE: SD Biosensor is recalling its STANDARD Q COVID-19 Ag Home Test in the United States, due to confirmed reports that the test kits were illegally imported into the United States. The STANDARD Q COVID-19 Ag Home Test is not authorized, cleared or approved by the FDA for distribution or use in the United States. There is no known distribution of these tests directly to consumers.  
BACKGROUND: STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample. 
RECOMMENDATIONS:
In the unlikely event that consumers in the United States encounter the 'STANDARD Q COVID-19 Ag Home Test', they are encouraged to discard and avoid any use the test, as it has not been authorized, cleared or approved by the FDA for use in COVID-19 testing and diagnosis in the United States. 

Consumers that have used the test are strongly encouraged to consider retesting with an FDA authorized or cleared test.

Health professionals and patients consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and click this link to: submit the report online.
Click here to: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax 1-800-FDA-0178 (1-800-332-0178)

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February 7, 2022, NJLINCS Health Alert Network, Distributed by the New Jersey Department of Health 
Subject: Public Health Info: FDA Issues Warning Regarding E25Bio COVID-19 Direct Antigen Rapid Test (DART)

 The U.S. Food and Drug Administration (FDA) is warning people not to use the E25Bio COVID-19 Direct Antigen Rapid Test (DART). This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States, and it may include false labeling representing that the test is authorized by the FDA. The E25Bio COVID-19 Direct Antigen Rapid Test (DART) may also be sold under the trade name E25Bio SARS-CoV-2 Antigen Test Kit.

The FDA is concerned about the risk of false results when using this test because E25Bio has not provided the FDA with adequate data demonstrating that the test’s performance is accurate.  In addition, the FDA is aware that the E25Bio COVID-19 Direct Antigen Rapid Test (DART) was sold directly to consumers and may have been accompanied by labeling with instructions for collecting a sample from deep inside the nose, reaching the back of the throat (nasopharyngeal) or from the middle part of the throat (pharynx) just beyond the mouth (oropharyngeal), which could result in serious injury when this is not done by trained professionals. 

The FDA has not received reports of injuries, adverse health consequences, or death associated with use of the E25Bio COVID-19 Direct Antigen Rapid Test.

This safety communication provides:  Important recommendations for people tested with the E25Bio COVID-19 Direct Antigen Rapid Test, health care providers and testing program organizers. Details on the issue and the FDA’s actions to address the issue. Instructions for reporting problems with this, and any COVID-19 test, to the FDA, Click here to go to the FDA website, for the February 4, 2022 recall notice..  

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 January 31, 2022 NJLINCS Health Alert Network, Distributed by the New Jersey Department of Health 
The U.S. Food and Drug Administration (FDA) issued a safety communication on January 28, 2022, warning people to stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test.
 
These tests were distributed with labeling indicating they are authorized by the FDA, but neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States.  The FDA is concerned about the potentially higher risk of false results when using unauthorized tests.

Empowered Diagnostics is recalling the CovClear COVID-19 Rapid Antigen Test and the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test, and the FDA has identified this issue as a class I recall, the most serious type of recall. 
This safety communication provides: Recommendations for test users, caregivers, health care personnel, and testing program organizers.  Details on the issue and the FDA’s actions to address the issue.  Instructions for reporting problems with tests to the FDA.  A link to the January 28, 2022 Recall Notice.  







Protection

Older adults and people who have severe underlying chronic medical conditions such as heart or lung disease or diabetes seem to be at higher risk for developing more serious complications from COVID-19 illness. Please consult with your health care provider about additional steps you may be able to take to protect yourself.

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Prevention

If you are sick with COVID-19 or think you might have it, follow the steps below to help protect other people in your home and community.

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