CLASS I ONGOING Device recall · Reported 14 Dec 2022 · FDA Enforcement Report
Dewei DNA/RNA Preservation Kit recalled by Dewei Medical Equipment Co
Dewei Medical Equipment Co is recalling Dewei DNA/RNA Preservation Kit, distributed in California, Florida, Kentucky, Michigan. The recall was initiated on 9 Aug 2022 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0323-2023
- FDA event ID
- 91137
- Recalling firm
- Dewei Medical Equipment Co, Foshan, N/A
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 9 Aug 2022
- FDA classified
- 7 Dec 2022
- Reported
- 14 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 9 Aug 2022 | Recall initiated by company | |
| 7 Dec 2022 | Classified by FDA | +120 days |
| 14 Dec 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Products were distributed in the United States without FDA authorization or clearance.
Product as listed by the FDA
Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
Where it was distributed
US Distribution in states to: CA, FL, KY, and MI.
Questions about this recall
Is Dewei DNA/RNA Preservation Kit recalled?
Yes. Dewei Medical Equipment Co recalled Dewei DNA/RNA Preservation Kit on 9 Aug 2022. The recall is Class I and its status is Ongoing. Recall number Z-0323-2023.
Why was it recalled?
Products were distributed in the United States without FDA authorization or clearance.
Which lots are affected?
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
Where was it sold?
US Distribution in states to: CA, FL, KY, and MI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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