If you have a Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit on the shelf, check the label. More than 56,000 of the COVID-19 tests are being recalled because they could provide inaccurate results.
According to the U.S. Food and Drug Administration (FDA), the products were found to have been distributed without appropriate premarket clearance or approval which potentially could result in inaccurate test results due to lack of performance evaluation by the FDA.
The following styles/models/UDI have been recalled:
Name of Product: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit
Products were distributed with “Skippack Medical Lab” branded Instructions for Use leaflets in three different packaging boxes identified below:
Purple and white box under “Skippack Medical Lab” brand: (see image below)
Green and white box under “DiagnosUS” brand: (see image below)
White box without brand name: (see image below)
Universal Meditech Inc. voluntarily recalled the product after becoming aware of the violative distribution notified by the FDA. To date, there has not been any reported injury.
What to do
Consumers who have Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits should stop using the device immediately and contact the distributor for product return.
Recalled products were manufactured from October 2021 to December 2021 and distributed in January 2022.
Consumers with questions may contact the legal attorney of the company via telephone at +1(702)871-9888 between the hours of 9 AM and 5 PM, P.S.T. Consumers may also contact the legal attorney of the company via e-mail at firstname.lastname@example.org.