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BreathID Hp Lab Device (WIN)

MERIDIAN BIOSCIENCE ISRAEL LTD · Model VS02000W · UDI-DI 07290016923391

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The BreathID® Hp Lab System is intended for use to non-invasively measure changes in the 13CO2/ 12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Hp Lab System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp Lab System consists of the appropriate IDkit: Hp™ kit, and the BreathID® Hp device, Auto Sampler and Lab Application

Recalls

Date	Firm	Reason
2011-06-07	Exalenz Bioscience Ltd	The product is in violation of the FD&C Act in that it was illegally marketed without proper clearance (no 510(k) submitted).
2007-05-02	Meretek Diagnostics, Inc.	Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.