WASHINGTON -Thousands of rapid tests for COVID-19 are part of a recall due to the chance it could give users the wrong test results.
Universal Meditech Inc. has initiated a nationwide recall of 56,300 Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits. The company says they were distributed without “appropriate premarket clearance or approval” which could lead to inaccurate results since their performance was not properly evaluated by the FDA.
The following styles/models/UDI have been recalled:
- Name of Product: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit
- UDI: None
- Model: Cassette
- Quantity: 56,300
Products were distributed with “Skippack Medical Lab” branded ‘Instructions for Use’ leaflet in three different packaging boxes identified below:
- Purple and white box under “Skippack Medical Lab” brand
- Green and white box under “DiagnosUS” brand
- White box without brand name
Those who have this test should stop using the device and contact the distributor for a product return.
If you have questions on the recall can contact the company’s attorney at (702)871-9888 between the hours of 9 a.m. and 5 p.m., P.S.T. or by email at firstname.lastname@example.org.