BioMerieux SA: Medical Device Recall in 2018 - (Recall #: Z-2172-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Oxidase Reagent (ref: 55635): This test is used to detect the production of the enzyme cytochrome oxidase by bacteria. This enzyme is characteristic of the genus Neisseria and most species of Pseudomonas. It enables the differentiation of Gram (-) bacilli (1, 2). A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

Product Classification:

Class II

Date Initiated: March 23, 2018

Date Posted: June 20, 2018

Recall Number: Z-2172-2018

Event ID: 80111

Reason for Recall:

A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.

Status: Terminated

Product Quantity: 4 boxes of OXIDASE REAGENT with 50 - 0.75ML bottles

Code Information:

Oxidase Reagent (ref: 55635): Lot number 92366601

Distribution Pattern:

International distribution.

Voluntary or Mandated:

Voluntary: Firm initiated