The US FDA is warning consumers and healthcare providers to not use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) because these tests are not authorized, cleared, or approved by the FDA.

According to an agency alert, “the FDA is concerned about the risk of false results when using this test because SML Distribution LLC has not provided the FDA with adequate data to show the tests work correctly.”

The unauthorized Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) uses a nasal swab sample to detect proteins, called antigens, from the SARS-CoV-2, the virus that causes COVID-19. It uses one of two types of swab samples: nasal (anterior nares) or nasopharyngeal.

SML Distribution LLC initiated a recall for the tests in March 2022. The FDA now identifies this as a Class I recall, the most serious type of recall. The company sent a Medical Device Recall letter to customers, distributors, and other U.S. consignees requesting them to take the following actions:

  • Immediately stop using these tests.
  • If the tests were distributed to third parties, perform a recall from all purchasers.
  • Return all COVID-19 tests distributed by SML Distribution LLC to SML Distribution LLC.

The FDA said it has not received reports of injuries or death associated with use of the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold).


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RT delivers in-depth coverage of the clinical, regulatory, and technology landscape for respiratory therapy—and reaches more than 28,000 key decision-makers and influencers. As one of healthcare’s most important data companies, we facilitate the rapid adoption of medical devices and practice management tools into the industry.