FDA Enforcement
Class I
Ongoing
Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING
Recall: Z-0929-2023
·
Reported February 8, 2023
Enforcement
- Recall Number
- Z-0929-2023
- Event ID
- 91321
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Universal Meditech Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 8, 2023
- Initiation Date
- November 28, 2022
- Classification Date
- January 27, 2023
- Address
- 1320 E Fortune Avenue, Suite 102, N/A, Fresno, CA, 93725, United States
Description
Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING
Reason
Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.
Code Info
Model Number: 550-10 UDI Code: None Lot Numbers: UL-AG-2111-01-Q UL-AG-2111-02-Q UL-AG-2110-05-Q UL-AG-2112-02-Q UL-AG-2110-03-Q UL-AG-2110-04-Q
Distribution
U.S. Nationwide distribution in the states of CA, and TX.
Quantity
56,300 kits