The U.S. Food and Drug Administration has recalled E25Bio rapid COVID-19 tests because the tests were not approved by the agency, may give false results, and may injure the user.
This is a “Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death,” the FDA said in a news release Friday.
The tests are sold under the product name E25Bio COVID-19 Direct Antigen Rapid Test and the trade name E25Bio SARS-CoV-2 Antigen Test Kit. Consumers who purchased the tests should throw them in the trash and health care providers who used the tests should consider re-testing patients.
“E25Bio is recalling its COVID-19 Direct Antigen Response Tests (DART) for several reasons, particularly that these tests were marketed and distributed to U.S. customers without authorization, clearance, or approval from the FDA,” the FDA said.
“Labeling distributed with some of the tests also includes inaccurate claims and instructions, including a statement that misrepresents the test as FDA-authorized.”The FDA said the kit may give users false-positive or false-negative results, which could result in the spread of the virus or a person delaying medical treatment.
The kits instruct users to obtain samples from deep inside the nose or throat, which could injure consumers, the FDA said.
“Only trained health care providers should collect these types of swab samples to prevent serious injury,” the FDA said, noting there have been no reports of such injuries.
Most at-home COVID tests require consumers to collect a sample with a nasal swab.
The FDA issued an alert on Feb. 4 warning consumers not to use the tests and posted the recall notice Friday. The company sent a letter to consumers in January telling them not to use the tests.
you or someone you know has been diagnosed with carcinoid tumors in the lung, you may wonder what they are and how they’re different from other types of lung cancer.
Carcinoid tumors are a rare type of lung cancer. Only 1% to 2% of lung cancers are carcinoid tumors. They usually grow slowly. They are a type of neuroendocrine tumor, meaning that they start in special cells, called neuroendocrine cells, that are found in the lungs and throughout the body.
Types of Carcinoid Tumors
It’s important for you to know what kind of carcinoid tumor you have to get the best treatment. Carcinoid tumors are divided in two types: typical and atypical.
Typical carcinoid tumors are the most common. About 9 out of 10 carcinoid tumors are called typical. They grow slowly, and they don’t usually spread outside of the lungs.Causes and Risk Factors
Researchers don’t really know the causes of carcinoid tumors in the lung. They have found that typical carcinoids don’t seem to be linked to smoking, but atypical carcinoid tumors are found more often in people who do smoke.
You may be at a higher risk for these rare tumors with:
Age. You can get carcinoid tumors at any age, but they happen most often in people 45 to 55 years old.
Gender. Carcinoid tumors are more common in women than in men.Chest X-rays may show whether any tumors are in your lungs. Some may be too small or in locations that can’t be seen with standard X-rays.
CT scans use X-rays and a computer to give a cross-section view of your lungs and can also show if any tumors have spread to other organs, such as your liver.
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