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U.S. Department of Health and Human Services

Class 2 Device Recall Transport Culture Medium

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  Class 2 Device Recall Transport Culture Medium see related information
Date Initiated by Firm July 06, 2020
Create Date February 04, 2022
Recall Status1 Terminated 3 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 2		 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.
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