Recall Z-1619-2021 ยท QKO Reagent, Coronavirus Serological
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.
| Date | Apr 26, 2021 |
| Status | Completed |
| 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 distr |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.