FDAClass IIMay 18, 2022

Diagnostic Kit SARS-cCo V Antigen Rapid Test recall

Diagnostic Kit SARS-cCo V Antigen Rapid Test

Why was Diagnostic Kit SARS-cCo V Antigen Rapid Test 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog/Model/Part Number: None UDI Code: None Lot Numbers: Unknown/None

Product
Diagnostic Kit SARS-cCo V Antigen Rapid Test
Recalling firm
USA Medical, LLC
Quantity
2055 kits
Distribution
U.S. Nationwide distribution in the states of CA, FL, IN, MD, MO, NJ, OK, and TN.
Recall date
May 18, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls