By: Sarah Doiron, Jocelina Joiner
Posted: February 14, 2023 / 11:13 am CST
Updated: Feb 14, 2023 / 11:13 am CST
(WPRI) — More than 56,000 COVID-19 rapid test kits are being recalled because they may not produce accurate results, according to the Food and Drug Administration.
Meditech Inc. University distributed 56,300 Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits nationwide last month without receiving approval to do so, according to the FDA.
Because the rapid test kits have not been formally evaluated and have not received “the appropriate premarket clearance or approval,” the FDA said, the accuracy of their results is unknown.
The rapid test kits were produced from October 2021 to December 2021 and distributed in January 2022 in three different types of packaging:
- Purple and white box with “Skippack Medical Lab” branding.
- Teal and white box with “DiagnosUS” branding.
- Unbranded white box
The company has distributed the affected products to California and Texas distributors.
The same device was previously recalled last year by SML Distribution LLC and distributed in Alabama, Florida, Georgia, Missouri, New York, Texas and Wyoming.
Anyone who has one of the recalled rapid test kits is advised not to use it and to contact Universal Meditech Inc. for instructions on how to return it.
