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BreathTek UBT for H. pylori 01Recalls & reported problems

Meridian Bioscience, Inc. · The BreathTek UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adults, and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment is used at least 4 weeks following completion of therapy. For there purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ration of 13CO2 to 12CO2 in breath samples, in clinical laboratories and point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results. The BreathTek UBT Kit is for administration by the heath care professional, as ordered by a licensed health care practitioner. · Class 3

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840733101434), received between Mar 28, 2022 and Jan 13, 2023 — classified as 2 injuries.

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 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Constipation1
  • Vomiting1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT COMPLETED UBT TESTING ON (B)(6) 2023 AT 8:04AM. CUSTOMER NOTED THAT WHEN LEAVING THE UBT TESTING, PATIENT HAD A HEADACHE SIMILAR TO A PAST MIGRAINE BUT HAD INDICATED THAT SHE HAD NOT HAD A MIGRAINE IN OVER A YEAR. PATIENT WENT HOME AND WAS EXPERIENCING NAUSEA, VOMITING, DIARRHEA, AND "TALKING OUT OF HER HEAD". PATIENT BEGAN VOMITING AROUND NOON (12:00PM). AT 2:00PM, SHE WAS TAKEN TO THE EMERGENCY ROOM BY HER HUSBAND WHERE SHE WAS DIAGNOSED WITH A HYPERTENSIVE EMERGENCY. IT WAS NOTED THAT A HEMORRHAGE WAS SEEN ON HER CT SCAN. CUSTOMER REPORTED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN THE AFTERNOON ON (B)(6) 2023. CUSTOMER REPORTED THAT THE DISCHARGE NOTED MENTIONED THAT THERE WERE NO ACUTE FINDINGS. WHILE THERE IS NO INDICATION THAT THE PERFORMANCE OF OR RESULTS PROVIDED BY THE BREATHTEK CAUSED OR CONTRIBUTED TO THE PATIENT'S CONDITION, MERIDIAN BIOSCIENCE HAS ELECTED TO SUBMIT AN MDR OUT OF AN EXTREME ABUNDANCE OF CAUTION.

    Patient problems: Vomiting

    MAUDE report 16161261 ↗
  • InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem

    PATIENT REPORTED COMPLICATIONS AFTER DRINKING PRANACTIN-CITRIC SOLUTION. PATIENT SAID SHE HAD "BUBBLE GUTS" FOR 20 MINUTES AFTER DRINKING SOLUTION AND THEN DID NOT PRODUCT STOOL FOR 4 DAYS AFTER. PATIENT REPORTED COMPLICATIONS AFTER DRINKING PRANACTIN-CITRIC SOLUTION. PATIENT SAID SHE HAD "BUBBLE GUTS" FOR 20 MINUTES AFTER DRINKING SOLUTION AND THEN DID NOT PRODUCT STOOL FOR 4 DAYS AFTER. THE PRODUCT LABELING INCLUDES A PRECAUTIONARY STATEMENT REGARDING THAT THOSE WHO ARE HYPERSENSITIVE TO MANNITOL SHOULD AVOID TAKING THE DRUG SOLUTION. HYPERSENSITIVITY IS A KNOWN REACTION THAT IS ALSO IDENTIFIED WITHIN THE LABELINGS POST-MARKETING EXPERIENCES SECTION.

    Patient problems: Constipation

    MAUDE report 13930298 ↗

Sources and updates

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