Jiangsu Well Biotech Co recall
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Why was Jiangsu Well Biotech Co recalled?
Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number: CO-02 UDI-DI Code: No UDI Codes provided Lot Numbers: 202107192, 202108231, 202109231, 202111082, 202110111, 202201102,
- Product
- Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
- Recalling firm
- Jiangsu Well Biotech Co.,Ltd.
- Quantity
- 620,000 tests
- Distribution
- U.S.: CA (pending firm supplying additional distribution locations/consignee list). O.U.S.: N/A
- Recall date
- October 19, 2022
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)