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Open, Classified

VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022

FDA Recall Z-2024-2023 · Posted 2023-06-28

Recalling FirmLuminex Corporation
Recall StatusOpen, Classified
Product CodeOZN
Date Initiated2023-06-05
Product Quantity114 units

Reason for Recall

It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.

Firm Action

Luminex issued an Urgent Field Safety Notice - Medical Device Recall notice on 06/05/2023 by email. The notice explained the problem with the stool prep kit, the risk, and requested isolation/quarantine, cease of use, and disposal of the affected products.

Root Cause

Other

Distribution Pattern

Worldwide and US Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123197VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)Nanosphere, Inc. · 2012-12-05

Official Source

View FDA Recall →

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

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