Recall Z-0001-2023— Jiangsu Well Biotech Co.,Ltd.

Name: FDA recall Z-0001-2023
Creator: U.S. Food and Drug Administration
Published: 2022-08-09

Class I · Ongoing

Class I FDA medical device recall by Jiangsu Well Biotech Co.,Ltd., initiated 2022-08-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02. Reason: Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance..

Recalling firm: Jiangsu Well Biotech Co.,Ltd.
Classification: Class I
Status: Ongoing
Initiated: 2022-08-09
Firm location: Changzhou, N/A, China

Product description

Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

Reason for recall

Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.

Data sourced from openFDA. This site is unofficial and independent of the FDA.