CLASS I Device recall · Reported 9 Jun 2021 · FDA Enforcement Report
Leccurate Sars-CoV-2, Antibody Rapid Test Kit recalled
Lepu Medical Technology (beijing) Co is recalling Leccurate Sars-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1, distributed in Florida, Georgia, Illinois, New York, Puerto Rico. The recall was initiated on 26 Apr 2021 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1619-2021
- FDA event ID
- 87737
- Recalling firm
- Lepu Medical Technology (beijing) Co, Beijing
- Classification
- Class I
- Status
- Completed
- Recall initiated
- 26 Apr 2021
- FDA classified
- 28 May 2021
- Reported
- 9 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 26 Apr 2021 | Recall initiated by company | |
| 28 May 2021 | Classified by FDA | +32 days |
| 9 Jun 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Is Leccurate Sars-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 recalled?
Yes. Lepu Medical Technology (beijing) Co recalled Leccurate Sars-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 on 26 Apr 2021. The recall is Class I and its status is Completed. Recall number Z-1619-2021.
Why was it recalled?
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.
Which lots are affected?
All Lots distributed within the U.S.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Lepu Medical Technology (beijing) Co
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Leccurate Sars-CoV-2, Antigen Rapid Test Kit recalled | Lepu Medical Technology (beijing) Co | Other | 5 states |
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