BioMerieux SA: Medical Device Recall in 2018 - (Recall #: Z-2168-2018)

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:

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.

Product Classification:

Class II

Date Initiated: March 23, 2018

Date Posted: June 20, 2018

Recall Number: Z-2168-2018

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: 135 (78 boxes of various product) in total

Code Information:

VITEK¿ 2 AST-N233 (ref: 413117): Lot Number 6330343103

Distribution Pattern:

International distribution.

Voluntary or Mandated:

Voluntary: Firm initiated