FDA Class 1 Recall: Imported, Non-FDA Approved COVID-19 Tests
This is a reprint of an FDA Alert.
Jiangsu Well Biotech Co., Ltd. Recalls COVID-19 Ag Rapid Test Devices That Are Not Authorized, Cleared, or Approved by the FDA
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.
October 12, 2022
- Product Name: COVID-19 Ag Rapid Test Device
- Product Codes: See Recall Database Entry
- Distribution Dates: July 23, 2021 to January 23, 2022
- Devices Recalled in the U.S.: 110,000
- Date Initiated by Firm: August 22, 2022
The COVID-19 Ag Rapid Test Device uses patient samples collected by nasal, nasopharyngeal, or oropharyngeal swab to detect proteins, called antigens, found on the SARS-CoV-2 virus. These tests are intended to be used by health care professionals.
Reason for Recall
Jiangsu Well Biotech Co., Ltd. is recalling COVID-19 Ag Rapid Test Devices because they were distributed to U.S. customers without authorization, clearance, or approval from the FDA. The company has not provided the FDA with adequate validation data to show that the test's performance is accurate. This means there is a risk of potential false negative, false positive, or misinterpretation of results.
Use of these tests may cause serious adverse health consequences or death. There is also a risk of injury if users follow any labeling instructions directing self-collection of nasopharyngeal or oropharyngeal samples.
There have been no complaints or reports of injuries or deaths.
Who May be Affected
- Distributors of the COVID-19 Ag Rapid Test Device.
- People who were tested for SARS-CoV-2 using the COVID-19 Ag Rapid Test Device.
- Health care providers and other organizations who used the COVID-19 Ag Rapid Test Device.
What to Do
On August 22, 2022, Jiangsu Well Biotech Co., Ltd. sent an email to distributors, and other U.S. consignees requesting they take the following actions:
- Immediately stop using and distributing these tests.
- Distributors should forward the recall information to any affected customer accounts who received the product.
- Complete a response form and return it to the firm.
Customers with questions about this recall should contact sales AT wellbioscience DOT com.
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.