Recall Z-0929-2023— Universal Meditech Inc.
Class I · Ongoing
Class I FDA medical device recall by Universal Meditech Inc., initiated 2022-11-28. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Universal Meditech Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2022-11-28
- Firm location
- Fresno, CA, United States
Product 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 for recall
Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.
Data sourced from openFDA. This site is unofficial and independent of the FDA.