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U.S. Department of Health and Human Services

Class 1 Device Recall Viral Transport Container

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  Class 1 Device Recall Viral Transport Container see related information
Date Initiated by Firm July 12, 2022
Create Date August 08, 2022
Recall Status1 Open3, Classified
Recall Number Z-1400-2022
Recall Event ID 90602
Product Classification Transport medium, notified per the VTM guidance - Product Code QMC
Product HXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made
Code Information No UDI. All lots distributed in the US.
Recalling Firm/
Manufacturer		 Haimen Shengbang Laboratory Equipment Co. Ltd.
D, Sanhe
No. 50 Xue Qian Road; Sanhezhen Haimen
Nantong China
For Additional Information Contact Lei Fan
86-189-38033981
Manufacturer Reason
for Recall		 Distributed VTM outside of VTM Guidance and without clearance.
FDA Determined
Cause 2		 No Marketing Application
Action The firm distributed a recall notification via email on 07/12/2022 dated 07/11/2022. This notification identifies the reason for recall to be that all vials of VTM distributed to the United States had not obtained 510K clearance and they weren't approved by FDA under the VTM Enforcement Policy. Customers are asked to identify any unused product and destroy it on-site. Additionally, testing institutions that have used product should evaluate previously obtained test results and evaluate the need to re-test patients. The firm has communicated they intend to apply to FDA for 510K clearance in the future for the recalled device. Customers with any questions are to conact Lei Fan at +86-18938033981 or market@hbxl.net.
Quantity in Commerce 100,000 total units
Distribution Worldwide distribution - US Nationwide distribution in the states of CA, FL, IL & NY. The country of China.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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