Diagnostic Kit SARS-cCo V Antigen Rapid Test
Reported: May 18, 2022 Initiated: April 4, 2022 #Z-1050-2022
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.
Details
- Recalling Firm
- USA Medical, LLC
- Units Affected
- 2055 kits
- Distribution
- U.S. Nationwide distribution in the states of CA, FL, IN, MD, MO, NJ, OK, and TN.
- Location
- Grapevine, TX
Frequently Asked Questions
What product was recalled? ▼
Diagnostic Kit SARS-cCo V Antigen Rapid Test. Recalled by USA Medical, LLC. Units affected: 2055 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 18, 2022. Severity: Moderate. Recall number: Z-1050-2022.
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