Changzhou, N/A, China
Jiangsu Well Biotech Co.,Ltd. recalls
1 recall recorded since 2018, most recently on 9 August 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 9 August 2022
- 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.
- Distribution
- U.S.: CA (pending firm supplying additional distribution locations/consignee list). O.U.S.: N/A
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0001-2023
- Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.