Fecal Extraction Device 504837Recalls & reported problems

Inova Diagnostics, Inc. · -100 ea. fecal extraction devices containing 2.8 mL of extraction buffer -100 ea. white caps · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08426950846833), received between Dec 9, 2022 and Dec 9, 2022 — classified as 1 injury.

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

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Device Handling Problem1
Use of Device Problem1

Patient problems

Limb Pain1

Recent adverse event reports

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

InjuryDec 9, 2022Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem
ON (B)(6)2022, THE PATIENT (SPECIAL CHEMISTRY TECHNOLOGIST, HEALTHCARE PROFESSIONAL) FILED A SUPERVISOR'S INCIDENT INVESTIGATION AT LABCORP REPORTING RIGHT ARM HAND PAIN AND NUMBNESS. THE INJURY WAS SUSPECTED TO BE DUE TO THE CONTINUAL REPETITIVE MOTION OF PERFORMING BIOLOGICAL SAMPLE EXTRACTIONS. THE PATIENT ONLY RAN CALPROTECTIN TESTING AND HAD DIFFICULTY USING THE FECAL EXTRACTION DEVICE. THE EMPLOYEE REPORTED HANDLING BETWEEN 600-900 SAMPLES IN A SINGLE SHIFT, USING THE SAME REPETITIVE MANUAL MOTION. IT WAS NOTED THAT THE PATIENT WAS SCHEDULED FOR FURTHER MEDICAL EVALUATION BY ORTHOPEDIC STAFF AT THAT TIME. THIS INCIDENT WAS NOT REPORTED TO INOVA DIAGNOSTICS AT THIS TIME. ON (B)(6)2022, INOVA DIAGNOSTICS WAS CONTACTED BY THE LABCORP OF AMERICA CUSTOMER AGAIN TO REQUEST SPECIAL TOOLS TO AID IN OPENING A HIGH VOLUME OF FECAL EXTRACTION DEVICES. THEY REPORTED THAT THE FECAL EXTRACTION DEVICE VOLUME HAD GROWN AS THE LABORATORY IS PROCESSING OVER 25,000 SAMPLES PER MONTH. THERE WERE NO PERMANENT WRIST INJURIES OR CARPAL TUNNEL DIAGNOSES REPORTED WITH CURRENT USERS, HOWEVER, THE INJURY THAT OCCURRED IN 2020 WAS SHARED WITH INOVA DIAGNOSTICS AT THIS TIME AS EVIDENCE OF A PAST INJURY W
Patient problems: Limb Pain
MAUDE report 15950317 ↗

Device details

UDI-DI	`08426950846833`
Brand	Fecal Extraction Device
Model	504837
Company	Inova Diagnostics, Inc.
Product code	NXO · Calprotectin, Fecal
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 14, 2025

Device type (GMDN): Faecal specimen collection kit IVD, clinical

A collection of devices intended exclusively for professional use for the sampling and containment of a small, predetermined amount of faecal matter from a primary faecal specimen, for subsequent laboratory analysis and/or other investigation. It typically consists of a specimen container (e.g., tube with a cap) with or without an additive/medium (e.g., cell or nucleic acid preservative solution, Carey-Blair transport medium, extraction buffer), and a sampling tool (e.g., swab, brush or spatula). This is a single-use device.

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.