Z-2172-2018 Class II Terminated
FDA device recall Z-2172-2018 was initiated by BioMerieux SA on Mar 23, 2018 and is designated Class II. 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… The recall status is terminated (terminated Jun 23, 2020). Affected quantity: 4 boxes of OXIDASE REAGENT with 50 - 0.75ML bottles.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 20, 2018
- Initiation Date
- Mar 23, 2018
- Termination Date
- Jun 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 boxes of OXIDASE REAGENT with 50 - 0.75ML bottles
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.
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.
Distribution Pattern
International distribution.
Code Information
Oxidase Reagent (ref: 55635): Lot number 92366601
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2172-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026