The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Product Name: Dewei Medical Equipment Co. DNA/RNA Preservation Kits
- Product Catalog Number: DW-80005-1B
- Distribution Dates: May 2020 to January 2022
- Devices Recalled in the U.S.: 250,000
- Date Initiated by Firm: August 19, 2022
Dewei Medical Equipment Co. DNA/RNA Preservation Kits are inactivated viral transport media, used for the collection, preservation, and transportation of clinical samples that will be tested for viruses that may include SARS-CoV-2 (the virus that causes COVID-19), influenza, avian influenza, hand, foot, and mouth disease, measles, norovirus, and rotavirus.
Reason for Recall
Dewei Medical Equipment Co. is recalling DNA/RNA Preservation Kits because these products were distributed to U.S. customers without authorization, clearance, or approval from the FDA. This means there is a risk for false negative, false positive, or misinterpretation of results if these products are used to detect SARS-CoV-2 or other viruses. Use of these products may cause serious adverse health consequences or death.
There have been no complaints, reports of injuries, or deaths associated with the use of this product.
Who May be Affected
- People whose test samples were collected, preserved, and transported using Dewei Medical Equipment Co. DNA/RNA Preservation kits.
- Health care personnel who are in possession of or may have used Dewei Medical Equipment Co. DNA/RNA Preservation kits to collect and store, and transport specimen samples from patients.
- Distributors of the Dewei Medical Equipment Co. DNA/RNA Preservation kits who have received or are in possession of these products.
What to Do
On August 19, 2022, Dewei Medical Equipment Co. sent electronic messages to several distributors informing them of the recall. In addition, those messages offered the following recommendations:
- Stop use of Dewei Medical Equipment Co. DNA/RNA Preservation Kits.
- Do not distribute Dewei Medical Equipment Co. DNA/RNA Preservation Kits.
- Inform any sub-distributors or end-users that they should not be using these products.
Customers with questions about this recall should contact Dewei Medical Equipment Co. at email@example.com.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program, using an online form, regular mail, or FAX.