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Z-2168-2018 Class II Terminated

Recalled by BioMerieux SA — Marcy L'Etoile, N/A

FDA device recall Z-2168-2018 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: 135 (78 boxes of various product) in total.

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: 135 (78 boxes of various product) in total

Product Description

The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic gram negative bacilli to antimicrobial agents. Fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.

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 AST-N233 (ref: 413117): Lot Number 6330343103

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2168-2018
openFDA file date: Oct 26, 2026
Loaded by RegDataLab: Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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