HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1
Summary
The FDA issued a Class I for HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1 by Haimen Shengbang Laboratory Equipment Co. Ltd.. Reason: Distributed VTM outside of VTM Guidance and without clearance..
Details
Source
Device Recall
External ID
Z-1399-2022
Action Date
2022-08-17
Status
Ongoing
Category
device
Product Description
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1
Lot/Code Info: No UDI. All lots distributed in the US.
Quantity Affected: 3,950,000 total units
Reason for Recall
Distributed VTM outside of VTM Guidance and without clearance.
Distribution
Worldwide distribution - US Nationwide distribution in the states of CA, FL, IL & NY. The country of China.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-12
Company
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 96 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Haimen Shengbang Laboratory Equipment Co. Ltd. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Haimen Shengbang Laboratory Equipment Co. Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Haimen Shengbang Laboratory Equipment Co. Ltd. have FDA actions?
Haimen Shengbang Laboratory Equipment Co. Ltd. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1399-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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