Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

API NH (REF 10400) API NH is a standardized system Recalled by Biomerieux France Chemin De L'Or Due to bioM¿rieux identified a visual defect and activity issue...

Date: November 8, 2013
Company: Biomerieux France Chemin De L'Or
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Biomerieux France Chemin De L'Or directly.

Affected Products

API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catharrhalis (Branhamella catarrhalis), which uses miniaturized tests, as well as a specially adapted database. API NH also enables the biotyping of Haemophilus influenza and Haemophilus parainfluenxzae, as well as the detection of a penicllinase.

Quantity: 39439 kits (includes ZYM B reagents, API Listeria * API NH kits)

Why Was This Recalled?

bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false negative results of some API biochemical tests using the ZYM B reagent.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Biomerieux France Chemin De L'Or

Biomerieux France Chemin De L'Or has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report