Recall record at a glance
| Official record | Z-1620-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Completed |
| Recalling firm | LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD |
| Report date | Jun 9, 2021 |
| Recall initiation date | Apr 26, 2021 |
| Quantity | 8, 419, 545 units in total |
| Location | Beijing, China |
Official product description
Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).
Why the product was recalled
Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution in the U.S.
Distribution information
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.
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.