FDA Medical Device Recalls (openFDA)
Gentueri Inc: Gentueri Viral Transport Medium (VTM), Sterile, IVD
- Recall number
- Z-0504-2022
- Recalling firm
- Gentueri Inc
- Product
- Gentueri Viral Transport Medium (VTM), Sterile, IVD
- Status
- Terminated
- Initiated
- 2021-03-18
- Posted
- not on file
- Terminated
- 2023-08-28
- Reason
- Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing.
- 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 ghunter@gentueri.com or 1-608-497-0366.
- Quantity
- 4,150 units
- Distribution
- US Nationwide distribution in the state of Indiana.
- Lot, serial or model codes
- CAT #: 3300-000; Lot #: 1142
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JSM
- Firm FEI
- 3017528620
- Firm city
- Verona
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28