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Open, Classified

HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type

FDA Recall Z-1398-2022 · Posted None

Recalling FirmHaimen Shengbang Laboratory Equipment Co. Ltd.
Recall StatusOpen, Classified
Product CodeQMC
Date Initiated2022-07-12
Product Quantity8,710,600total units

Reason for Recall

Distributed VTM outside of VTM Guidance and without clearance.

Firm 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 [email protected].

Root Cause

No Marketing Application

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of CA, FL, IL & NY. The country of China.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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