Z-0561-2022Class II

Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab

Name: Z-0561-2022 Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
Creator: Gentueri Inc
Published: 2020-07-06
License: https://open.fda.gov/license/

Gentueri Inc / initiated 2020-07-06 / Terminated / root cause: sterility

FDA source

Gentueri Inc began a recall of Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab on 2020-07-06. FDA classified it as Class II and gives the reason as "Kits failed sterility testing and showed evidence of contamination". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0561-2022
Classification: Class II
Status: Terminated
Initiated: 2020-07-06
Posted: 2022-02-04
Terminated: 2023-12-12
Recalling firm: Gentueri Inc
Product: Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
Product code: JSM Culture Media, Non-Propagating Transport
Reason for recall: Kits failed sterility testing and showed evidence of contamination.
Root cause tag: sterility
FDA root cause: Unknown/Undetermined by firm
Action: The firm distributed a notice to customers dated 07/06/2020 via email stating that lots 1029, 1029A, and 1029B need to be quarantined pending further investigation. Customers with questions are asked to contact Renee Schlick, Quality Assurance Manager, at 608-838-1640 or by email at [email protected].
Quantity in commerce: 13,975 units (2 mL in a 15 mL conical tube)
Distribution: Domestic: Illinois, Nebraska, and Wisconsin.
Product codes and lots: CAT#: 3300-000; Lot No.: 1029.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0561-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0561-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-16	2022-02-04

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)