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DENSICHEK® Plus 21250Recalls & reported problems

Biomerieux , Inc. · The DENSICHEK® Plus instrument is designed for use with the VITEK®2 System to measure the optical density of a microorganism suspension. · 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 03573026222239), received between Dec 18, 2020 and Dec 18, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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.

Most reported problems

Device problems

  • Incorrect, Inadequate or Imprecise Result or Readings1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionDec 18, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A FLUCTUATION IN THE TURBIDITY READING WHILE USING THE DENSICHECK ® PLUS INSTRUMENT (REFERENCE # 21250, SERIAL # (B)(4)). THE TURBIDITY (OPTICAL DENSITY) IS EXPRESSED IN UNITS OF MCFARLANDS (MCF). THIS ISSUE OCCURRED WHILE THE CUSTOMER PERFORMED MAINTENANCE INSTRUMENT VERIFICATION; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER HAS BEEN USING THIS INSTRUMENT SINCE 2014. THEY WERE PERFORMING MAINTENANCE INSTRUMENT VERIFICATION WITH A STANDARD KIT THAT WAS WITHIN EXPIRY WHEN THEY NOTICED THE READ VALUE FLUCTUATING. A FIELD SERVICE EXPERT (FSE) WENT TO THE CUSTOMER SITE TO CHANGE THE BATTERIES IN THE INSTRUMENT, PERFORM CLEANING OF THE TUBE INSERT AND REPLACE THE STANDARD KIT WITH A NEW ONE BUT THE ISSUE STILL OCCURRED. IT WAS RECOMMENDED THAT THE CUSTOMER REPLACE THEIR EXISTING INSTRUMENT. DENSICHEK® PLUS IS INTENDED FOR USE WITH THE VITEK® AND VITEK® 2 SYSTEMS TO MEASURE THE OPTICAL DENSITY OF A MICROORGANISM SUSPENSION. THIS MICROORGANISM SUSPENSION IS THEN ANALYZED WITH THE VITEK® OR VITEK® 2 INSTRUMENTS. THE REQUIRED MCF VALUES FOR MICROORGANISM SUSPENSIONS ARE SPECIFIED IN THE CULTURE REQUIREMENTS TABLE FOR VITEK®

    Patient problems: No Patient Involvement

    MAUDE report 11041589 ↗

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