Universal Meditech initiated a nationwide recall of 56,300 SARS-CoV-2 antigen rapid test kits that were distributed in January 2022.
The Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits 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. 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, the FDA says.
A recall of the same device has been previously conducted by SML Distribution LLC.
On Dec. 29, 2022, Universal Meditech initiated the nationwide recall. Recalled products were manufactured from October 2021 to December 2021.
Products were distributed with “Skippack Medical Lab” branded instructions-for-use leaflet in three different packaging boxes identified:
- Purple and white box under “Skippack Medical Lab” brand
- Green and white box under “DiagnosUS” brand
- White box without brand name
Universal Meditech voluntarily recalled the product after becoming aware of the violative distribution notified by the FDA. To date, there has not been any reported injury.
Universal Meditech is notifying its distributors and customers by phone and email and is arranging for return of all recalled products. The company has distributed the products to distributors in California and Texas.
Featured image: The recalled test’s green and white box, under the “DiagnosUS” brand. Photo: FDA
