FDA Class I recall: Jiangsu Well Biotech Co., Ltd. COVID-19 Ag rapid test devices

Oct. 14, 2022

Jiangsu Well Biotech Co., Ltd. has recalled its 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.

Recalled Product

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

Device Use

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.

FDA release

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