VITEK® COMPACT PRO 423465Recalls & reported problems

Biomerieux , Inc. · VITEK COMPACT PRO is an automated system that performs bacterial ID and AST. minimum, a total of 15 ID and/or AST cards can be processed simultaneously per run. can be extended to 30 or 60. · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03573026615499), received between Jul 30, 2026 and Jul 30, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Nonstandard Device” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Nonstandard Device1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 30, 2026Nonstandard Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50081717 ↗

Device details

UDI-DI	`03573026615499`
Brand	VITEK® COMPACT PRO
Model	423465
Company	Biomerieux , Inc.
Product code	LON · SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
Class	Class 2
FDA submission	K234012
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jan 23, 2026

Device type (GMDN): Microorganism identification/antimicrobial-susceptibility analyser IVD

An electrically-powered automated or semi-automated laboratory instrument intended to be used for the identification of bacteria and/or yeast isolated from clinical specimens and for the determination of their antimicrobial susceptibility profile using morphology, substrate utilization and/or biochemical reactivity and by monitoring growth rates and/or determining endpoint growth, against a range of antimicrobials. Growth detection technology used may include immunoassay, colorimetry, fluorimetry, chromatography and/or carbon dioxide production.

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All SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.