LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD: Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

Recall number

Z-1619-2021

Recalling firm

LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD

Product

Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

Status

Completed

Initiated

2021-04-26

Posted

not on file

Terminated

not on file

Reason

Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) is not authorized, cleared, or approved for marketing and/or distribution in the U.S.

Root cause

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

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.

Lot, serial or model codes

All Lots distributed within the U.S.

510(k) numbers

not on file

PMA numbers

not on file

Product code

QKO

Firm FEI

3008002401

Firm city

Beijing

Firm state

not on file

Firm country

China

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

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