Z-0001-2023Class I

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

Name: Z-0001-2023 Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Creator: Jiangsu Well Biotech Co.,Ltd.
Published: 2022-08-09
License: https://open.fda.gov/license/

Jiangsu Well Biotech Co.,Ltd. / initiated 2022-08-09 / Open, Classified

FDA source

Jiangsu Well Biotech Co.,Ltd. began a recall of Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02 on 2022-08-09. FDA classified it as Class I and gives the reason as "Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0001-2023
Classification: Class I
Status: Open, Classified
Initiated: 2022-08-09
Posted: 2022-10-08
Recalling firm: Jiangsu Well Biotech Co.,Ltd.
Product: Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Product code: QKP Coronavirus Antigen Detection Test System.
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.
FDA root cause: No Marketing Application
Action: On 08/30/2022, Jiangsu Well Biotech Co. Ltd, notified its U.S. Distributor, DIVOC Diagnostics LLC via email with an "IMPORTANT!!! Recall Notice" and followed up with an "URGENT: MEDICAL DEVICE RECALL" Letter informing them that Jiangsu Well Biotech is recalling the SDI LABS COVID-19 AG Rapid Test Device Cat#: CO-02 because these tests have not received FDA Emergency Use Authorization, nor have they been cleared or approved by FDA for commercial distribution in the U.S. Customers are asked to: 1. Stop using/distributing the COVID-19 Ag Rapid Test Device in their possession immediately; 2. Count the tests in their possession and write the number on the MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form and return the forms to Jiangsu Well Biotech via email 3. Return all unused product to Jiangsu Well Biotech 4. I the products have been further distributed, forward the recall information to all affected customers. For questions - contact Jiangsu Well Biotech Co. Ltd. via email at [email protected], or to Huiying Wang, General Manager at [email protected]
Quantity in commerce: 620,000 tests
Distribution: U.S.: CA (pending firm supplying additional distribution locations/consignee list). O.U.S.: N/A
Product codes and lots: Catalog Number: CO-02 UDI-DI Code: No UDI Codes provided Lot Numbers: 202107192, 202108231, 202109231, 202111082, 202110111, 202201102,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0001-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0001-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07

Product code QKP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)