FDAClass IDecember 14, 2022

Dewei DNA/RNA Preservation Kit recall

Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B

Why was Dewei DNA/RNA Preservation Kit recalled?

Products were distributed in the United States without FDA authorization 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?

LOT / EXP DW200628 27-Jun-21 DW200520 19-May-21 DW200520 19-May-21 DW201202 01-Dec-21 DW201202 1-Dec-21 DW210103 2-Dec-22 DW210926 25-Sep-22

Product
Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
Recalling firm
DEWEI MEDICAL EQUIPMENT CO LTD
Quantity
1,348,000 (US)
Distribution
US Distribution in states to: CA, FL, KY, and MI.
Recall date
December 14, 2022
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls