Recall Z-0929-2023 ยท QKP Coronavirus Antigen Detection Test System.
Universal Meditech Inc.
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
| Date | Jan 27, 2023 (initiated Nov 28, 2022) |
| Status | Open, Classified |
| Reason | Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization. |
| Root cause | No Marketing Application |
| Action | On 12/29/2022, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via email to customers informing them Universal Meditech Inc. is recalling SARS-CoV-2 Antigen Rapid Test Kits due to test kits being distributed with any FDA pre-market approvals, clearances and/or authorizations. Test kits are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits, or labelled and packaged in Green and white box under the brand name DiagnosUS, or packaged in White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING. Customer are instructed to: |
| Quantity | 56,300 kits |
| Distribution | U.S. Nationwide distribution in the states of CA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.