Z-0504-2022Class II

Gentueri Viral Transport Medium (VTM), Sterile, IVD

Name: Z-0504-2022 Gentueri Viral Transport Medium (VTM), Sterile, IVD
Creator: Gentueri Inc
Published: 2021-03-18
License: https://open.fda.gov/license/

Gentueri Inc / initiated 2021-03-18 / Terminated / root cause: manufacturing process

FDA source

Gentueri Inc began a recall of Gentueri Viral Transport Medium (VTM), Sterile, IVD on 2021-03-18. FDA classified it as Class II and gives the reason as "Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0504-2022
Classification: Class II
Status: Terminated
Initiated: 2021-03-18
Posted: 2022-01-18
Terminated: 2023-08-28
Recalling firm: Gentueri Inc
Product: Gentueri Viral Transport Medium (VTM), Sterile, IVD
Product code: JSM Culture Media, Non-Propagating Transport
Reason for recall: Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: The firm called the customer on 03/19/2021 and indicated that there was a possible contamination of Lot 1142 and that this needed to be held at distribution facilities. Following the conversation, Gentueri emailed as an attachment a "Removal Notification," for VTM Lot 1142 that explained that the lot failed to pass inspection and all product from this lot at the customer's site needed to be returned. Customers with any questions are to contact Gordon S. Hunter, Marketing Manager for Gentueri, at [email protected] or 1-608-497-0366.
Quantity in commerce: 4,150 units
Distribution: US Nationwide distribution in the state of Indiana.
Product codes and lots: CAT #: 3300-000; Lot #: 1142

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0504-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0504-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-26	2022-01-18

Product code JSM

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)