Z-1050-2022Class II

Diagnostic Kit SARS-cCo V Antigen Rapid Test

Name: Z-1050-2022 Diagnostic Kit SARS-cCo V Antigen Rapid Test
Creator: USA Medical, LLC
Published: 2022-04-04
License: https://open.fda.gov/license/

USA Medical, LLC / initiated 2022-04-04 / Open, Classified

FDA source

USA Medical, LLC began a recall of Diagnostic Kit SARS-cCo V Antigen Rapid Test on 2022-04-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1050-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-04
Posted: 2022-05-06
Recalling firm: USA Medical, LLC
Product: Diagnostic Kit SARS-cCo V Antigen Rapid Test
Product code: QKP Coronavirus Antigen Detection Test System.
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.
FDA root cause: No Marketing Application
Action: On 04/04/2022, US Medical LLC sent an "URGENT MEDICAL DEVICE RECALL" Letter via certified US Postal informing customers that USA Medical LLC is voluntarily recalling all COVID-19 Rapid test, labeled as Diagnostic Kit COVID-19 Antigen Rapid Test and may have included components labeled DiaTrust COVID-19 Ag Rapid Test. These COVID-19 antigen tests distributed by USA Medical have not received FDA Emergency Use Authorization, nor have these tests been cleared or approved by FDA for commercial distribution. Customers are instructed to: 1. Discontinue use, discard, or return the product back to USA Medical using the enclosed pre-paid Fed Ex return shipping label. 2. If you have further distributed these products, immediately notify these customers and provide them with the recall notification. 3. Please fill out and return that attached Acknowledgement and Receipt Form. Any further questions or require assistance: Contact Monday thru Friday 9:00am to 5:00pm Central time at 817-416-9900
Quantity in commerce: 2055 kits
Distribution: U.S. Nationwide distribution in the states of CA, FL, IN, MD, MO, NJ, OK, and TN.
Product codes and lots: Catalog/Model/Part Number: None UDI Code: None Lot Numbers: Unknown/None

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1050-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1050-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-06

Product code QKP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)