Class 2 Device Recall Transport Culture Medium

• Date Initiated by Firm: July 06, 2020
• Create Date: February 04, 2022
• Recall Status: Terminated on December 12, 2023
• Recall Number: Z-0561-2022
• Recall Event ID: 89336
• Product Classification: Culture media, non-propagating transport - Product Code JSM
• Product: Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
• Code Information: CAT#: 3300-000; Lot No.: 1029.
• Recalling Firm/ Manufacturer: Gentueri Inc; 312 Locust Dr; Verona WI 53593-2215
• For Additional Information Contact: Randy Nagy; 608-949-8568
• Manufacturer Reason for Recall: Kits failed sterility testing and showed evidence of contamination.
• FDA Determined 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 in Commerce: 13,975 units (2 mL in a 15 mL conical tube)
• Distribution: Domestic: Illinois, Nebraska, and Wisconsin.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.