> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Chinese Firm Recalls ‘Unauthorized’ Covid-19 Tests
- URL: https://www.fdaweb.com/chinese-firm-recalls-unauthorized-covid-19-tests/
- Published: 2022-10-12T12:00:00.000Z
- Updated: 2026-09-14T18:02:46.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152957

Jiangsu Well Biotech (Jiang Su Sheng, China) has recalled its Covid-19 Ag Rapid Test Devices because they were distributed without authorization, clearance, or approval from FDA. The company has not provided the agency with validation data to demonstrate the test’s performance is accurate, which could contribute to potential false negative, false positive, or misinterpretation of results, a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/jiangsu-well-biotech-co-ltd-recalls-covid-19-ag-rapid-test-devices-are-not-authorized-cleared-or?ref=fdaweb.com) says. “Use of these tests may cause serious adverse health consequences or death,” it says. The test reportedly uses patient samples collected by nasal, nasopharyngeal, or oropharyngeal swab to detect Covid-19 antigens, and is intended to be used by health care professionals.