Skip to content

Etest® ITRACONAZOLERecalls & reported problems

Biomerieux SA · Etest is a quantitative technique for determining susceptibility of clinically significant yeast. It provides a gradient of 15 doubling dilutions for MIC determination. · 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 03573026549091), received between Jun 20, 2018 and Jun 20, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect Or Inadequate Test Results” (1 report).

1 other recall cover devices cleared under the same FDA submission (K040560); they may or may not involve this specific model.

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.

Most reported problems

Device problems

  • Incorrect Or Inadequate Test Results1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJun 20, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OUT OF RANGE LOW RESULTS FOR INTERNAL QUALITY CONTROLS (QC) IN ASSOCIATION WITH ETEST® ITRACONAZOLE (REFERENCE 525858). THE CUSTOMER REPORTED THAT AT 24 HOURS THEY HAD A MIC VALUE OF 0.016 ON MULTIPLE TEST STRIPS. AT 48 HOURS THE CUSTOMER REPORTED TEST RESULTS OF 0.032. THE CUSTOMER HAS TESTED THE SAME LOT OF STRIPS WITH MULTIPLE LOTS OF ORGANISMS AND MEDIA. THE CUSTOMER ORDERED ANOTHER ORDER OF STRIPS, AND RECEIVED THE SAME LOT. THEY TESTED THE NEW KIT OF ETEST® STRIPS AND RECEIVED SIMILAR RESULTS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7620578 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040560. One submission often covers many models, so check the product and lot details in each record.

  • Z-0824-2023 · Nov 9, 2022 · Open, Classified
    ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333

Other Susceptibility Test Plate, Antifungal devices

All Susceptibility Test Plate, Antifungal devices →

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