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U.S. Department of Health and Human Services

Class 1 Device Recall Dewei DNA/RNA Preservation Kit

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 Class 1 Device Recall Dewei DNA/RNA Preservation Kitsee related information
Date Initiated by FirmAugust 09, 2022
Date PostedDecember 07, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0323-2023
Recall Event ID 91137
Product Classification Microbial nucleic acid storage and stabilization device - Product Code QBD
ProductDewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
Code Information 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
Recalling Firm/
Manufacturer		 DEWEI MEDICAL EQUIPMENT CO LTD
5 Th Floor
No.4 Building,Shiyou Industrial Park, Jun'An,Shunde
Foshan China
Manufacturer Reason
for Recall		Products were distributed in the United States without FDA authorization or clearance.
FDA Determined
Cause 2		No Marketing Application
ActionStarting on August 9, 2022, the firm contacted its customers through instant messaging to inform them that the affected products were not authorized, cleared, or approved by the FDA. Distributors were asked to cease selling and distributing the affected kits in U.S. immediately. On August 19, 2022, the firm followed up with its customers with an email stating the same. The firm has ceased exporting the DNA/RNA Preservation kits to the U.S. If you have any questions, email: sherry@deweilab.com.
Quantity in Commerce1,348,000 (US)
DistributionUS Distribution in states to: CA, FL, KY, and MI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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