SD Biosensor recalls STANDARD Q COVID-19 Ag Home Tests which are not cleared, approved or cleared by the FDA and may give false results

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The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices can result in serious injury or death.

Recalled product

  • Product Name: SD Biosensor STANDARD Q COVID-19 Ag Home Test
  • Product codes and batch numbers: see recall database Entrance
  • Distribution dates: August 26, 2021 to January 30, 2022
  • Devices recalled in the United States: up to 397,700 units
  • Company launch date: January 31, 2022

Use of the device

The SD Biosensor STANDARD Q COVID-19 Ag Home Test uses a nasal swab sample to detect proteins, called antigens, of SARS-CoV-2, the virus that causes COVID-19. This test is not cleared, cleared, or approved by the FDA for marketing or distribution in the United States.

Note: This reminder does not do not apply to the SD Biosensor COVID-19 At-Home test (also an antigen test), which was cleared by the FDA on December 24, 2021 and is distributed by Roche Diagnostics.

Reason for recall

SD Biosensor Inc. is recalling its STANDARD Q COVID-19 Ag home tests because these tests were distributed to US customers without FDA clearance, clearance, or approval.

As this test has not been cleared, cleared, or approved by the FDA, there is insufficient data to demonstrate that the performance of the test is accurate. This means that there is a risk of false negative and false positive test results. False negative results occur when the test does not detect the SARS-CoV-2 virus but the person is actually infected. False positive results occur when the test indicates that the person has the SARS-CoV-2 virus, but is not infected.

There have been no reports of injuries, adverse health consequences, or deaths associated with the use of the SD Biosensor STANDARD Q COVID-19 Ag Home Test.

Use of the affected product could have serious adverse health and death consequences. On March 1, 2022, the FDA issued a safety communication, Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests, warning users to discontinue use of these tests.

Who can be affected

  • Distributors of the SD Biosensor STANDARD Q COVID-19 Ag home test
  • Healthcare providers and other organizations who have used the SD Biosensor STANDARD Q COVID-19 Ag Home Test to test patients for COVID-19.
  • People who have been tested for COVID-19 using the SD Biosensor STANDARD Q COVID-19 Ag Home Test.

What to do

On February 2, 2022, SD Biosensor, Inc. issued a press release asking U.S. distributors and customers to take the following actions:

  • Do not use the STANDARD Q COVID-19 Ag home test.
  • Discard the test and avoid further use of the test.
  • Consumers who have used the test are strongly encouraged to consider retesting with an FDA cleared test.

The FDA safety communication offered additional recommendations, including:

  • Test users and caregivers: Speak to your health care provider if you think you have been tested with the STANDARD Q COVID-19 Ag Home Test and have concerns about your test results.
  • Healthcare providers and organizers of screening programs: If an antigen test was performed less than two weeks ago using the STANDARD Q COVID-19 Ag home test, consider retesting your patients using a SARS-CoV- diagnostic test. 2 cleared or cleared by the FDA if you suspect an inaccurate result. If the test was performed more than two weeks ago and there is no reason to suspect current SARS-CoV-2 infection, there is no need to retest.
  • Report any issues you have with the STANDARD Q COVID-19 Ag Home Test to the FDA, including suspected false results. See Report problems with your test.

Additionally, to adequately address the serious public safety concern that these tests may be used in the near future, the FDA is directing all distributors in the United States in possession of these products to:

  • Stop distributing and marketing these products. Contact SD Biosciences for assistance in removing these products from distribution or, alternatively, discarding or destroying these products.

Contact information

Customers with questions or concerns regarding this recall should contact 1-714-202-5789 or email info@lkconsultinggroup.com.

Additional Resources

How do I report a problem?

Healthcare professionals and consumers can report adverse reactions or quality issues they have experimented with using these devices for MedWatch: the FDA’s Safety Information and Adverse Event Reporting Program using an online form, mail, or fax .

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