Z-1398-2022Class I

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

Name: Z-1398-2022 HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type
Creator: Haimen Shengbang Laboratory Equipment Co. Ltd.
Published: 2022-07-12
License: https://open.fda.gov/license/

Haimen Shengbang Laboratory Equipment Co. Ltd. / initiated 2022-07-12 / Open, Classified

FDA source

Haimen Shengbang Laboratory Equipment Co. Ltd. began a recall of HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type on 2022-07-12. FDA classified it as Class I and gives the reason as "Distributed VTM outside of VTM Guidance and without clearance". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1398-2022
Classification: Class I
Status: Open, Classified
Initiated: 2022-07-12
Posted: 2022-08-08
Recalling firm: Haimen Shengbang Laboratory Equipment Co. Ltd.
Product: HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type
Product code: QMC Transport Medium, Notified Per The Vtm Guidance
Reason for recall: Distributed VTM outside of VTM Guidance and without clearance.
FDA root cause: 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 [email protected].
Quantity in commerce: 8,710,600total units
Distribution: Worldwide distribution - US Nationwide distribution in the states of CA, FL, IL & NY. The country of China.
Product codes and lots: No UDI. All lots distributed in the US.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1398-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1398-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-08-17	2022-08-08
Z-1399-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-08-17	2022-08-08
Z-1400-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-08-17	2022-08-08

Product code QMC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)