Dewei DNA/RNA Preservation Kits recalled for lack of FDA authorization
Dewei DNA/RNA Preservation Kits (catalog DW-80005-1B) were distributed in the U.S. without FDA authorization or clearance. Approximately 1,348,000 units were distributed to California, Florida, Kentucky, and Michigan.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4 per the rubric. No illnesses or injuries have been reported in the source material, so the severity remains at the Class I baseline of 4.
Plain-English summary
Dewei DNA/RNA Preservation Kit (catalog number DW-80005-1B), manufactured by Dewei Medical Equipment Co Ltd, was distributed in the United States without FDA authorization or clearance. Approximately 1,348,000 units were distributed to California, Florida, Kentucky, and Michigan.
Because the product was distributed without proper FDA authorization or clearance, its safety and effectiveness have not been established through FDA review. The FDA has classified this as a Class I recall.
Consumers and healthcare providers should discontinue use of any Dewei DNA/RNA Preservation Kit with catalog number DW-80005-1B. Affected lot numbers include DW200628, DW200520, DW201202, DW210103, and DW210926, with expiration dates ranging from May 2021 to December 2022. Contact the manufacturer for instructions on proper handling and return of the product.
The recalled product
- Product
- Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
- Manufacturer
- DEWEI MEDICAL EQUIPMENT CO LTD
- Affected units
- 1,348,000
Distribution
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