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Recall Observatory FDA recall evidence

Device product

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

Z-0323-2023

August 09, 2022

Class I

Product summary

Firm
DEWEI MEDICAL EQUIPMENT CO LTD
Event
Event 91137
Status
Ongoing
Classification
Class I
Quantity
1,348,000 (US)
Official record key
device-enforcement:Z-0323-2023

Official wording

Reason: Products were distributed in the United States without FDA authorization or clearance.

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

Distribution pattern: US Distribution in states to: CA, FL, KY, and MI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Products were distributed in the United States without FDA authorization or clearance.