Dewei Medical Equipment Co. recalls unapproved DNA/RNA Preservation Kits (DW-80005-1B) sold in the US. Products distributed without FDA clearance pose regulatory risks but no specific safety hazards are described.
Products were distributed in the United States without FDA authorization or clearance.
Dewei Medical Equipment Co. is recalling DNA/RNA Preservation Kits (DW-80005-1B) because they were sold in the US without FDA approval. This means the products lack regulatory safety checks but do not pose immediate physical risks like injury or fire.
The kits were distributed without FDA authorization, meaning they haven't undergone required safety and effectiveness testing. This could lead to improper use in medical settings, but the recall does not specify physical hazards like injury or fire.
Anyone who purchased the Dewei DNA/RNA Preservation Kit (DW-80005-1B) in the US. Laboratory users and medical professionals handling genetic samples are most at risk due to regulatory non-compliance.
Check for the catalog number DW-80005-1B on the kit. Products were sold with specific lot numbers from May 2020 through December 2022, including DW200628 (27-Jun-21), DW200520 (19-May-21), and others.
Look for the catalog number DW-80005-1B on the kit packaging or label.
The Dewei DNA/RNA Preservation Kit was distributed in the US without FDA authorization or clearance, meaning it hasn't undergone required safety and effectiveness testing.
The recall states the products were sold without FDA approval but does not describe any specific physical hazards like injury or fire.
Check for the catalog number DW-80005-1B and lot numbers from May 2020 through December 2022, including DW200628 (27-Jun-21), DW200520 (19-May-21), and others.
We’ve drafted a message you can send Dewei to request your refund or repair — edit it as you like.
Subject: Recall Z-0323-2023 — Dewei Dewei Hello, I own a Dewei that is covered by recall Z-0323-2023 from Dewei. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
