FDA Medical Device Recalls (openFDA)
USA Medical, LLC: Diagnostic Kit SARS-cCo V Antigen Rapid Test
- Recall number
- Z-1050-2022
- Recalling firm
- USA Medical, LLC
- Product
- Diagnostic Kit SARS-cCo V Antigen Rapid Test
- Status
- Open, Classified
- Initiated
- 2022-04-04
- Posted
- not on file
- Terminated
- not on file
- 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 distributed.
- 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
- 2055 kits
- Distribution
- U.S. Nationwide distribution in the states of CA, FL, IN, MD, MO, NJ, OK, and TN.
- Lot, serial or model codes
- Catalog/Model/Part Number: None UDI Code: None Lot Numbers: Unknown/None
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKP
- Firm FEI
- 3021504509
- Firm city
- Grapevine
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28