Summary
The FDA issued a Class II for Diagnostic Kit SARS-cCo V Antigen Rapid Test by USA Medical, LLC. Reason: COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distribut.
Details
Source
Device Recall
External ID
Z-1050-2022
Action Date
2022-05-18
Status
Ongoing
Category
device
Product Description
Diagnostic Kit SARS-cCo V Antigen Rapid Test
Lot/Code Info: Catalog/Model/Part Number: None UDI Code: None Lot Numbers: Unknown/None
Quantity Affected: 2055 kits
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
U.S. Nationwide distribution in the states of CA, FL, IN, MD, MO, NJ, OK, and TN.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-04
Company
Grapevine, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 140 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (USA Medical, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does USA Medical, LLC have FDA actions?
This is the only FDA action we have on record for USA Medical, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1050-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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