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 Listeria (REF 10300) API Listeria 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 Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as a database. The ZYM B reagent is including in API Listeria kit and it is used as an additional reagent for revealing the result of DIM miniaturized biochemical test included in the API Listeria strips. ZYM B reagent is added in the DIM test before reading miniaturized biochemical test including in the API Listeria strips.

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