Jiangsu Well Biotech Co.,Ltd.: Medical Device Recall in 2022 - (Recall #: Z-0001-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: August 9, 2022

Date Posted: October 19, 2022

Recall Number: Z-0001-2023

Event ID: 90773

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.

Status: Ongoing

Product Quantity: 620,000 tests

Code Information:

Catalog Number: CO-02 UDI-DI Code: No UDI Codes provided Lot Numbers: 202107192, 202108231, 202109231, 202111082, 202110111, 202201102,

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated