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Terminated

Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab

FDA Recall Z-0561-2022 · Posted None

Recalling FirmGentueri Inc
Recall StatusTerminated
Product CodeJSM
Date Initiated2020-07-06
Date Terminated2023-12-12
Product Quantity13,975 units (2 mL in a 15 mL conical tube)

Reason for Recall

Kits failed sterility testing and showed evidence of contamination.

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 [email protected].

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

Domestic: Illinois, Nebraska, and Wisconsin.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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