Universal Meditech Inc. Recalls Skippack Medical Lab COVID

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 patient samples to detect proteins, called antigens, found on the SARS-CoV-2 virus. The samples are collected in one of two ways:

Universal Meditech Inc. is recalling Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests (Colloidal Gold) because these tests were distributed to U.S. customers without authorization, clearance or approval from the FDA. Neither Universal Meditech Inc. nor SML Distribution LLC, has provided the FDA with adequate 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.

Use of the affected product may cause serious adverse health consequences or death.

Universal Meditech Inc. has received no complaints or reports of injuries, deaths, or adverse events.

On December 29, 2022, Universal Meditech Inc. sent a notification letter to 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 can call the legal attorney for Universal Meditech Inc. at (702) 871-9888 between 9:00 AM and 5:00 PM PST, or email [email protected].

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.

02/08/2023