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U.S. Department of Health and Human Services

Class 1 Device Recall The SARSCoV2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)

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  Class 1 Device Recall The SARSCoV2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) see related information
Date Initiated by Firm April 26, 2021
Create Date May 28, 2021
Recall Status1 Open3, Classified
Recall Number Z-1620-2021
Recall Event ID 87737
Product Classification Coronavirus antigen detection test system. - Product Code QKP
Product Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).

Code Information All Lots distributed within the U.S.
Recalling Firm/
Manufacturer
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
Building 7-1
NO. 37 Chaoqian Rd; Changping Tech Zone
Beijing China
Manufacturer Reason
for Recall
Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution in the U.S.
FDA Determined
Cause 2
No Marketing Application
Action On 4/26/2021, Lepu Medical issued an "Urgent: Medical Device Recall Notification" to all affected consignees. In addition, to informing consignees about the recall, Lepu asked consignees to take the following actions: (1) Quarantine and discontinue distribution of All Lots of the abovementioned products which were distributed to U.S. (2) Please complete the acknowledgement form and send to recall@lepu-medical.com within 5 business days. If you no longer have any of the recalled product, please also complete the acknowledgement form and return to us by email above. (3) If your firm has distributed the product, please provide all consignees with a copy of the recall notification. Please also identify the lots and quantities of products shipped to U.S. within the acknowledgement form. (4) We request you to remove the products from U.S. within 30 working days or contact us to discuss the solution. Please provide your intent and actions taken to remove remaining product from the US market. Disposal of Products 5. All Lots of the abovementioned products which were distributed to U.S. shall be removed from the U.S. market. Please either remove the products from U.S. within 30 working days. Please contact us immediately to assist with the removal of the products within the 30-working day requirement. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax: " Complete and submit the report Online: www.fda.gov/medwatch/report.htm " Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. 7. Should you have any further questions, please feel free to contact recall@lepu-medical.com
Quantity in Commerce 8, 419, 545 units in total
Distribution Worldwide Distribution: US Distribution to states of: FL, IL, NY, GA, Puerto Rico and OUS countries of: Canada, Honduras, Peru, Dominican, Bolivia, Colombia, Mexico, Brazil, Argentina, Guatemala, Venezuela, Ecuador, Chile, Paraguay, Panama, Costa Rica, Peru and Hong Kong.
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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