The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography)
- All lot codes
- Manufacturing Dates: Approximately March 20, 2020 to Present
- Distribution Dates: Approximately March 20, 2020 to Present
- Devices Recalled in the U.S.:
- At least 8,419,545 antibody tests
- At least 205,175 antigen tests
- Date Initiated by Firm: April 26, 2021
The Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit uses a nasal swab sample to detect proteins, called antigens, from the SARS-CoV-2 virus. The SARS-CoV-2 Antigen Rapid test is used to find out if a person has an active COVID-19 infection.
The Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) looks for antibodies in a person’s immune system produced in response to SARS-CoV-2, the virus that causes COVID-19, and should not be used to diagnose an active COVID-19 infection. The Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatoraphy) uses serum, plasma, or blood samples.
Reason for Recall
Lepu Medical Technology is recalling the SARS-CoV-2 Antigen Rapid Test Kit and Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) due to likely risk of false results. Neither test was authorized, cleared, or approved for marketing or distribution in the United States by the FDA.
There have been no reports of injuries or death from use of these tests.
Who May Be Affected
- Health care providers
- People who used these tests and caregivers
What to Do
For Health Care Providers, Test Users, and Caregivers
On May 28, 2021, the FDA issued a safety communication with recommendations for health care providers, test users, and caregivers. Read the safety communication, “Stop Using Lepu Medical Technology SARS-CoV-2 Antigen and Leccurate Antibody Tests: FDA Safety Communication" for detailed recommendations.
For Lepu Medical Technology Distributors
To adequately address the serious public safety concern that these tests could be used in the near future, the FDA instructs all U.S. distributors in the United States in possession of these products to take the following immediate actions:
- Stop distributing and marketing these products.
- Discard or destroy these products or alternatively, contact email@example.com for assistance in removing these products from distribution.
- Contact Lepu Medical Technology or your distributor for instructions about how to obtain the Lepu’s Urgent Medical Device Recall Notification.
Distributors, health care providers, test users and caregivers who have the SARS-CoV-2 Antigen Rapid Test Kit or the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) who have questions should contact firstname.lastname@example.org.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.