(WPRI) – More than 56,000 COVID-19 rapid test kits are being recalled because they might not produce accurate results, according to the Food and Drug Administration.
University Meditech Inc. distributed the 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.
Since the rapid test kits weren’t formally evaluated and did not receive “the appropriate premarket clearance or approval,” the FDA said, the accuracy of their results is unknown.
The rapid test kits were manufactured from October 2021 to December 2021 and distributed in January 2022 in three different types of packaging:
- Purple and white box under the “Skippack Medical Lab” brand
- Teal and white box under the “DiagnosUS” brand
- White box without a brand name
The company dispensed 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 tests kits is urged not to use it and to contact Unviersal Meditech Inc. for instructions on how to return it.