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The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The devices described in this recall notice are the same devices announced in the FDA safety communication, Do Not Use Skippack Medical Lab SARS-CoV-2 COVID-19 Tests.
The Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) uses a nasal swab sample to detect proteins, called antigens, found on the SARS-CoV-2 virus.
SML Distribution LLC is recalling these tests because these tests were distributed to U.S. customers without authorization, clearance or approval from the FDA. In addition, SML Distribution LLC did not provide the FDA with adequate validation data to show that the test’s performance is accurate. This means there is a risk of potential false negative, false positive, or misinterpretation of results.
If you use the affected product, this may cause serious adverse health consequences or death.
SML Distribution has received no complaints or reports of injuries, deaths, or adverse events.
On March 20, 2022, SML Distribution LLC sent a Medical Device Recall letter to customers, distributors, and other U.S. consignees requesting them to take the following actions:
The FDA’s Safety Communication offered recommendations for other affected parties, including:
Customers with questions about this recall should contact SML Distribution LLC by e-mailing techsupport@smldistribution.com or calling 888-209-4406.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices, including suspected false results or injuries from self-swabbed nasopharyngeal or oropharyngeal samples, to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or fax.