Haimen Shengbang Laboratory Equipment Co. Ltd. Recalls Viral Transport Media Containers That Are Not Authorized, Cleared, or Approved by the FDA | FDA

2023-03-26 02:36:39 By : Ms. shelly bian

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Haimen Shengbang Laboratory Equipment Co. Ltd. Recalls Viral Transport Media Containers That Are Not Authorized, Cleared, or Approved by the FDA | FDA

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.

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.

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.

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:

Customers with questions about this recall should e-mail: market@hxbl.net or call 1-424-240-4910.

Haimen Shengbang Laboratory Equipment Co. Ltd. Recalls Viral Transport Media Containers That Are Not Authorized, Cleared, or Approved by the FDA | FDA

Nasal Swabs 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.