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U.S. Department of Health and Human Services

Class 2 Device Recall Diagnostic Kit SARScCo V Antigen Rapid Test

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  Class 2 Device Recall Diagnostic Kit SARScCo V Antigen Rapid Test see related information
Date Initiated by Firm April 04, 2022
Create Date May 06, 2022
Recall Status1 Open3, Classified
Recall Number Z-1050-2022
Recall Event ID 90098
Product Classification Coronavirus antigen detection test system. - Product Code QKP
Product Diagnostic Kit SARS-cCo V Antigen Rapid Test
Code Information Catalog/Model/Part Number: None UDI Code: None Lot Numbers: Unknown/None
Recalling Firm/
Manufacturer		 USA Medical, LLC
1220 Texan Trl Ste 205
Grapevine TX 76051-4164
For Additional Information Contact
817-416-9900
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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