FDA recall Z-0001-2023

Jiangsu Well Biotech Co.,Ltd. · Class I · device

Product

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.

Distribution

U.S.: CA (pending firm supplying additional distribution locations/consignee list). O.U.S.: N/A

Key facts

Status
Ongoing
Initiation date
2022-08-09
Report date
2022-10-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Changzhou, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0001-2023