| Class 1 Device Recall Viral Transport Container | |
Date Initiated by Firm | July 12, 2022 |
Create Date | August 08, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1399-2022 |
Recall Event ID |
90602 |
Product Classification |
Transport medium, notified per the VTM guidance - Product Code QMC
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Product | HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1 |
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
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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 | 3,950,000 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 |
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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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