Gentueri Inc: Medical Device Recall in 2022 - (Recall #: Z-0561-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab

Product Classification:

Class II

Date Initiated: July 6, 2020

Date Posted: February 16, 2022

Recall Number: Z-0561-2022

Event ID: 89336

Reason for Recall:

Kits failed sterility testing and showed evidence of contamination.

Status: Terminated

Product Quantity: 13,975 units (2 mL in a 15 mL conical tube)

Code Information:

CAT#: 3300-000; Lot No.: 1029.

Distribution Pattern:

Domestic: Illinois, Nebraska, and Wisconsin.

Voluntary or Mandated:

Voluntary: Firm initiated