More than 56,000 COVID-19 antigen rapid test kits have been recalled because they were distributed without appropriate clearance or approval by the U.S. Food & Drug Administration.
In a news release issued on Friday, the FDA said that Universal Meditech Inc. issued the nationwide recall of 56,300 Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits.
The kits could potentially cause inaccurate test results, according to the FDA.
The agency said that the products being recalled were manufactured from October 2021 to December 2021 and distributed in January 2022.
They were distributed with a “Skippack Medical Lab” branded Instructions for Use leaflet in three different packaging boxes, the FDA said. They were a purple and white box under “Skippack Medical Lab” brand, green and white box under “DiagnosUS” brand, and a white box that did not have a brand name.
Universal Meditech Inc. voluntarily recalled the test kits after learning of the distribution violation from the FDA. The company has distributed the products to companies in California and Texas, the FDA said.
Universal Meditech Inc. has distributed the products to distributors in California and Texas. There have been no reported injuries, the FDA stated in its release.
Consumers with questions can contact the company’s legal attorney at 702-871-9888 from 12 p.m. to 8 p.m. EST. Customers can also contact the company via email at m@linlawgroup.com.