LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD Recall 87737
Description: 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.
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD Recall 87737 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1619-2021 |
| Event ID | 87737 |
| Event Description | 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 Type | Devices |
| 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. |
| Quantity | 8, 419, 545 units in total |
| Recall 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. |
| Device Classification | 20210609 |
| Device Code Info | All Lots distributed within the U.S. |
| Center Classification Date | 20210528 |
| Recall Initiation Date | 20210426 |
| Recalling Firm | LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD |
| Initial Notification | |
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