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Open, Classified

Diagnostic Kit SARS-cCo V Antigen Rapid Test

FDA Recall Z-1050-2022 · Posted None

Recalling FirmUSA Medical, LLC
Recall StatusOpen, Classified
Product CodeQKP
Date Initiated2022-04-04
Product Quantity2055 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.

Firm 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

Root Cause

No Marketing Application

Distribution Pattern

U.S. Nationwide distribution in the states of CA, FL, IN, MD, MO, NJ, OK, and TN.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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