Enteric Pathogens (EP) Stool Sample Preparation Kit 30-002-023Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840487101568), received between May 2, 2023 and May 2, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Chemical Problem” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

4 other recalls cover devices cleared under the same FDA submission (K140083); 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 5, 2023Class IIOpen, Classified

   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.

   Z-2023-2023 · Root cause: Other · Recall details · FDA record ↗

2. Jun 17, 2022Class IIOpen, 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-1335-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2023Chemical Problem; Chemical Problem

  ON (B)(6) 2023, (B)(6) HOSPITAL NOTIFIED LUMINEX THAT THEY OBSERVED THEIR EP STOOL PREP KIT NOT ABSORBING THE CARY BLAIR BUFFER PROPERLY. THE CUSTOMER WAS UNAWARE OF WHICH SPECIFIC KIT THE SWABS ORIGINATED FROM. LOT OF SWAB PROVIDED: 247P17 - LN:202699 EXP 4/30/2025; EP KIT LOT NOT KNOWN AS STOOL PREP KITS WERE SEPARATED FROM SHIPMENT. NO PATIENT SAMPLES WERE AFFECTED BY THE SWAB CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16854218 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140083. One submission often covers many models, so check the product and lot details in each record.

• Z-2451-2021 · Aug 3, 2021 · Open, Classified
  Verigene EP Amplification Reagent Kit Test
• Z-1488-2021 · Mar 18, 2021 · Open, Classified
  VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.
• Z-2009-2021 · Oct 30, 2020 · Open, Classified
  Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
• Z-2685-2014 · Oct 10, 2013 · Terminated
  The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and gen