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Open, Classified

Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023

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

Recalling FirmLuminex Corporation
Recall StatusOpen, Classified
Product CodePCH
Date Initiated2023-06-05
Product Quantity3987 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

Official Source

View FDA Recall →

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

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