Z-2165-2018 Class II Terminated
FDA device recall Z-2165-2018 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: 2 boxes of NH TEST KIT with 20 Cards.
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
- 2 boxes of NH TEST KIT with 20 Cards
Product Description
The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the VITEK 2 Systems for the automated identification of most clinically significant fastidious organisms. The VITEK 2 NH identification card is a single-use disposable. 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
VITEK 2 NH (ref: 21346): Lot Number 2450355203
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2165-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026