Clostridium difficile (CDF) Stool Sample Preparation Kit 30-002-022Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (K123197); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jun 17, 2022Open, Classified

   There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.

   Z-1334-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123197. One submission often covers many models, so check the product and lot details in each record.

• Z-2024-2023 · Jun 5, 2023 · Open, Classified
  VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
• Z-2010-2021 · Oct 30, 2020 · Open, Classified
  Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
• Z-2168-2014 · Oct 16, 2013 · Terminated
  Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. The Verigene Clostridium difficile Nucleic Acid
• Z-2682-2014 · Oct 10, 2013 · Terminated
  The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcd