FDA Medical Device Recalls (openFDA)
Gentueri Inc: Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
- Recall number
- Z-0561-2022
- Recalling firm
- Gentueri Inc
- Product
- Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
- Status
- Terminated
- Initiated
- 2020-07-06
- Posted
- not on file
- Terminated
- 2023-12-12
- Reason
- Kits failed sterility testing and showed evidence of contamination.
- 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 rschlick@gentueri.com.
- Quantity
- 13,975 units (2 mL in a 15 mL conical tube)
- Distribution
- Domestic: Illinois, Nebraska, and Wisconsin.
- Lot, serial or model codes
- CAT#: 3300-000; Lot No.: 1029.
- 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