The Recall Desk
SevereFDA (Devices)·Z-0323-2023·Announced 2022-12-14

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Category
Medical Device — Laboratory / Specimen Preservation
Hazard
  • unapproved-medical-device
  • unauthorized-distribution

Distribution

Distributed in 4 states:

  • CA
  • FL
  • KY
  • MI

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