Z-1619-2021Class I

Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for...

Name: Z-1619-2021 Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for...
Creator: Lepu Medical Technology (Beijing) Co., Ltd
Published: 2021-04-26
License: https://open.fda.gov/license/

Lepu Medical Technology (Beijing) Co., Ltd / initiated 2021-04-26 / Completed

FDA source

LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD began a recall of Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to... on 2021-04-26. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-1619-2021
Classification: Class I
Status: Completed
Initiated: 2021-04-26
Posted: 2021-05-28
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.
Product code: QKO Reagent, Coronavirus Serological
Reason for recall: 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.
FDA 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 [email protected] 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 [email protected]
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.
Product codes and lots: All Lots distributed within the U.S.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1619-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1619-2021	Class I	Completed	Voluntary: Firm initiated	2021-06-09	2021-05-28
Z-1620-2021	Class I	Completed	Voluntary: Firm initiated	2021-06-09	2021-05-28

Product code QKO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)