Z-1050-2022 Class II Ongoing
FDA device recall Z-1050-2022 was initiated by USA Medical, LLC on Apr 4, 2022 and is designated Class II. Reason for recall: COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed. The recall status is ongoing. Affected quantity: 2055 kits.
Recall Details
- Product Type
- Devices
- Report Date
- May 18, 2022
- Initiation Date
- Apr 4, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2055 kits
Product Description
Diagnostic Kit SARS-cCo V Antigen Rapid Test
Reason for Recall
COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.
Distribution Pattern
U.S. Nationwide distribution in the states of CA, FL, IN, MD, MO, NJ, OK, and TN.
Code Information
Catalog/Model/Part Number: None UDI Code: None Lot Numbers: Unknown/None
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1050-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026