Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall CovClear COVID19 Rapid Antigen Test

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 1 Device Recall CovClear COVID19 Rapid Antigen Test see related information
Date Initiated by Firm December 22, 2021
Create Date January 29, 2022
Recall Status1 Completed
Recall Number Z-0480-2022
Recall Event ID 89315
Product Classification Coronavirus antigen detection test system. - Product Code QKP
Product CovClear COVID-19 Rapid Antigen Test, ATG 900-031
Code Information All lots
Recalling Firm/
Manufacturer		 Empowered Diagnostics LLC
3341 W Mcnab Rd
Pompano Beach FL 33069-4808
Manufacturer Reason
for Recall		 COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
FDA Determined
Cause 2		 No Marketing Application
Action The firm notified their direct consignees by letter delivered by email on December 22, 2021. The letter explained the hazard and requested the discontinuation of use and distribution. Those who has further distributed the products, were requested to conduct a sub-recall.
Quantity in Commerce 284,575 units
Distribution US Nationwide Distribution
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.
-
-