VITEK® MS MYCOBACTERIUM/NOCARDIA KITRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03573026436971), received between Oct 14, 2019 and Dec 30, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION OF RHIZOPUS ARRHIZUS AS ASPERGILLUS TERREUS COMPLEX IN ASSOCIATION WITH THE VITEK® MS (REF 410895) AND THE VITEK® MS MYCOBACTERIUM/NOCARDIA KIT (REF 415659). THE CUSTOMER INDICATED THAT SOMETIMES THEY HAVE ISSUES WITH OBTAINING IDENTIFICATIONS FOR RHIZOPUS ARRHIZUS AND CRYPTOCOCCUS CURVATUS STRAINS, AND STATED THAT THEY HAD OBTAINED A MISIDENTIFICATION OF A RHIZOPUS ARRHIZUS STRAIN AS ASPERGILLUS TERREUS COMPLEX. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX INITIATED AN INTERNAL INVESTIGATION FOR THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13118735 ↗
• MalfunctionJul 8, 2021Burst Container or Vessel; Burst Container or Vessel

  PRODUCT INTENDED USE: THE VITEK® MS MYCOBACTERIUM/ NOCARDIA KIT PROVIDES THE REAGENTS AND CONSUMABLES NEEDED TO PROCESS SAMPLES BY PROTEIN EXTRACTION AND INACTIVATION FOR MYCOBACTERIUM AND NOCARDIA IDENTIFICATION USING THE VITEK® MS SYSTEM. DESCRIPTION OF THE ISSUE: A CUSTOMER FROM THE UNITED STATES REPORTED THAT A BEAD TUBE FROM THE VITEK MS MYCOBACTERIUM / NOCARDIA KIT (REF. 415659 ¿ LOT 1008403350) BURST DURING THE INACTIVATION PROCESS. THE CUSTOMER REPORTED THAT WHEN PERFORMING STEP 3 OF THE INACTIVATION PROCESS (DISRUPTION OF THE CELLS), THE BEAD TUBE (TUBE WITH GLASS BEAD) USED WITH THE CUSTOMER BEAD DISRUPTOR BURST. THE TEST WAS PERFORMED USING BIOSAFETY LEVEL 3 PRACTICES AS INDICATED THE INSTRUCTION FOR USE. THE BEAD DISRUPTOR INSTRUMENT HAD AN ENCLOSURE AND WAS LOCATED INSIDE A BIOLOGICAL SAFETY CABINET. LABORATORY TECHNICIANS WORE PERSONAL PROTECTIVE EQUIPMENT (PPE). THEREFORE, THERE WAS NO LABORATORY TECHNICIAN EXPOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139440 ↗
• MalfunctionMay 10, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INTENDED USE: THE VITEK® MS MYCOBACTERIUM/NOCARDIA KIT PROVIDES THE REAGENTS AND CONSUMABLES NEEDED TO PROCESS SAMPLES BY PROTEIN EXTRACTION AND INACTIVATION FOR MYCOBACTERIUM AND NOCARDIA IDENTIFICATION USING THE VITEK® MS SYSTEM. THE VITEK® MS SYSTEM IS A MASS SPECTROMETER USING MALDI-TOF (MATRIX-ASSISTED LASER DESORPTION/IONIZATION-TIME OF FLIGHT) TECHNOLOGY FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM CLINICAL SPECIMENS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF LONG DRYING TIME USING THE VITEK® MS MYCOBACTERIUM/NOCARDIA KIT - REFERENCE 415659 LOT #51065. THE CUSTOMER REPORTED LONG SAMPLE DRYING ISSUE, SOMETIMES >5 HOURS, AFFECTING BOTH QUALITY CONTROL SAMPLES AND CLINICAL SAMPLES. THE ISSUE CAUSES ACQUISITION TO ONLY BE POSSIBLE THE NEXT DAY; THEREFORE THERE IS DELAY IN RESULTS >24 HOURS. NO PATIENT IMPACT HAS BEEN DISCLOSED BY THE CUSTOMER AS A CONSEQUENCE OF DELAYED RESULTS. BIOMÉRIEUX GLOBAL CUSTOMER SERVICE (GCS) RECOMMENDED THE FOLLOWING SETUP PROTOCOL TO ASSIST WITH THE DRYING TIME: - USE A HALOGEN (NOT LED) BULB OF 50 WATTS - TURN THE LAMP ON - POSITION THE BULB ABOUT 18-20 CM FROM THE SLIDES - PERFORM SLIDE DEPOSITS AS USUAL (CAN B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11801027 ↗
• MalfunctionMay 10, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  INTENDED USE: THE VITEK® MS SYSTEM, REFERENCE 410895, IS A MASS SPECTROMETER USING MALDI-TOF (MATRIX-ASSISTED LASER DESORPTION/IONIZATION-TIME OF FLIGHT) TECHNOLOGY FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM CLINICAL SPECIMENS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION OF MB. INTRACELLULARE AS N. AFRICANA WHEN USING THE VITEK® MS SYSTEM (REFERENCE 410895, SERIAL NUMBER #(B)(4)), AS COMPARED TO PCR TEST. WHEN TESTING WITH THE MYCOBACTERIUM/ NOCARDIA KIT FOR VITEK MS, THE SYSTEM IDENTIFIED N. AFRICANA WITH A CONFIDENCE LEVEL OF 99.7 % INSTEAD OF MB. INTRACELLULARE. AS IT WAS A QC TESTING OF THE KIT, NO PATIENT RESULTS WERE AFFECTED. THE METHOD USED TO IDENTIFY THE MB. INTRACELLULARE WAS AN EXTRACTION AND PCR. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11799146 ↗
• MalfunctionOct 14, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF MYCOBACTERIUM TUBERCULOSIS COMPLEX (MTBC) AS MYCOBACTERIUM CELATUM WHEN TESTING A PATIENT ISOLATE WITH THE VITEK® MS MYCOBACTERIUM/NOCARDIA KIT (REF 415659, LOT 1007187830). THE STRAIN WAS SENT TO A REFERENCE LABORATORY AND WAS IDENTIFIED AS MTBC BY GENETIC SEQUENCING. THE CUSTOMER STATED THAT THE MISIDENTIFICATION CAUSED A DELAY IN REPORTING RESULTS TO THE PHYSICIAN, BUT NO INCORRECT RESULTS WERE REPORTED AND NO INAPPROPRIATE TREATMENT WAS PROVIDED. ALTHOUGH TREATMENT WAS DELAYED WHILE THE IDENTIFICATION WAS BEING VERIFIED, THERE IS NO REPORT OR INDICATION FROM THE LABORATORY THAT THE DELAY IN TREATMENT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9187136 ↗