Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
Summary
The FDA issued a Class I for Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B by DEWEI MEDICAL EQUIPMENT CO LTD. Reason: Products were distributed in the United States without FDA authorization or clearance..
Details
Source
Device Recall
External ID
Z-0323-2023
Action Date
2022-12-14
Status
Ongoing
Category
device
Product Description
Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
Lot/Code Info: 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
Quantity Affected: 1,348,000 (US)
Reason for Recall
Products were distributed in the United States without FDA authorization or clearance.
Distribution
US Distribution in states to: CA, FL, KY, and MI.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-09
Company
Foshan, N/A
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DEWEI MEDICAL EQUIPMENT CO LTD) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DEWEI MEDICAL EQUIPMENT CO LTD have FDA actions?
This is the only FDA action we have on record for DEWEI MEDICAL EQUIPMENT CO LTD in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0323-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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