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: Viral Transport Media Containers
- Brand names HXBL, WETEX, or Genesis Biomedical, with part numbers HX-K59, HX-K59-1, and “custom made” (saline).
- Product Serial Numbers:
- Distribution Dates: October 8, 2021 to February 15, 2022
- Devices Recalled in the U.S.: 4,165,200
- Date Initiated by Firm: July 12, 2022
Haimen Shengbang Laboratory Equipment Co. Ltd.’s Viral Transport Media Container is a sampling swab and a tube containing viral sampling medium (the liquid that maintains a specimen sample while it is transported to a laboratory for testing).
This container and swab are used to collect specimens for transport to a laboratory for viral testing to detect infection, including testing for viruses such as SARS-CoV-2, the virus that causes COVID-19.
Reason for Recall
Haimen Shengbang Laboratory Equipment is recalling Viral Transport Media Containers 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.
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 and transported in Haimen Shengbang Laboratory Equipment Viral Transport Media Containers.
- Health care personnel who used the Haimen Shengbang Laboratory Equipment Viral Transport Media Containers to collect and store specimen samples from patients.
- Distributors of the Haimen Shengbang Laboratory Equipment Viral Transport Media Containers.
What to Do
On July 12, 2022, Haimen Shengbang Laboratory Equipment sent an email to customers, distributors, and other U.S. consignees requesting them to take the following actions:
- Immediately destroy all Viral Transport Media Containers.
- Evaluate previous test results where this product was used and determine if patients should be re-tested.
Customers with questions about this recall should e-mail: email@example.com or call 1-424-240-4910.
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.