VITEK® 2 COMPACT 27415Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03573026220624), received between Oct 17, 2022 and Apr 14, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (1 report).

1 FDA recall record name this device's identifier.

5 other recalls cover devices cleared under the same FDA submission (K050002); 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.

Recalls naming this device

1. Jan 28, 2021Terminated

   bioMrieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. The problem is when HL7 Connection is used, the results in the VITEK 2 do not match the results sent to the LIS and the Laboratory Technician would need to change results in the LIS to match those in the VITEK 2. If the isolate is sent more than once to LIS, a software defect prevents the system from sending the expertised interpretation results and the Therapeutic Corrections (TC) is not sent to Laboratory Information Systems (LIS).

   Z-1308-2021 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2023Failure to Back-Up; Failure to Back-Up

  INTENDED USE: THE VITEK® 2 SYSTEM IS INTENDED FOR THE AUTOMATED QUANTITATIVE OR QUALITATIVE ANTIMICROBIAL SUSCEPTIBILITY TESTING OF ISOLATED COLONIES FOR MOST CLINICALLY SIGNIFICANT AEROBIC GRAM-NEGATIVE BACILLI, STAPHYLOCOCCUS SPP., ENTEROCOCCUS SPP., STREPTOCOCCUS SPP., AND YEAST. THE VITEK® 2 SYSTEM IS ALSO INTENDED FOR THE AUTOMATED IDENTIFICATION OF MOST CLINICALLY SIGNIFICANT ANAEROBIC ORGANISMS AND CORYNEBACTERIUM SPECIES, FERMENTING AND NON FERMENTING GRAM-NEGATIVE BACILLI, GRAM-POSITIVE ORGANISMS, FASTIDIOUS ORGANISMS, AND YEASTS AND YEAST-LIKE ORGANISMS. DESCRIPTION: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF RESULT NOT ACCESSIBLE IN ASSOCIATION WITH VITEK 2 COMPACT 15 (REF. (B)(4), SERIAL NUMBER: (B)(4)). THE CUSTOMER REPORTED OBTAINING AN ERROR MESSAGE STATING: "IMPOSSIBLE TO FIND THE ISOLATE OR AN ERROR OCCURRED WHEN RETRIEVING IT". THE PC WAS RESTARTED TWICE, BUT THE ERROR WAS NOT RESOLVED AND RESULT WAS NOT ACCESSIBLE. BIOMÉRIEUX CUSTOMER SERVICE RECOMMENDED THAT THE CUSTOMER RESTART ANALYSIS. THE RESULTS WERE DELAYED BY MORE THAN 24 HOURS. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S/USER'S STA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744657 ↗
• MalfunctionOct 17, 2022Application Program Problem; Application Program Problem

  INTENDED USE: THE VITEK® 2 SYSTEM IS INTENDED FOR THE AUTOMATED QUANTITATIVE OR QUALITATIVE ANTIMICROBIAL SUSCEPTIBILITY TESTING OF ISOLATED COLONIES FOR MOST CLINICALLY SIGNIFICANT AEROBIC GRAM-NEGATIVE BACILLI, STAPHYLOCOCCUS SPP., ENTEROCOCCUS SPP., STREPTOCOCCUS SPP., AND YEAST. THE VITEK® 2 SYSTEM IS ALSO INTENDED FOR THE AUTOMATED IDENTIFICATION OF MOST CLINICALLY SIGNIFICANT ANAEROBIC ORGANISMS AND CORYNEBACTERIUM SPECIES, FERMENTING AND NON FERMENTING GRAM-NEGATIVE BACILLI, GRAM-POSITIVE ORGANISMS, FASTIDIOUS ORGANISMS, AND YEASTS AND YEAST-LIKE ORGANISMS. ISSUE DESCRIPTION: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF A SPECIMEN RESULT BEING INACCESSIBLE IN ASSOCIATION WITH VITEK 2 COMPACT 15 (B)(4). CUSTOMER REPORTED THAT THEY OBTAINED A MESSAGE: "THE ISOLATE COULD NOT BE FOUND OR AN ERROR OCCURRED WHEN RETRIEVING IT". THE PC WAS RESTARTED TWICE, BUT THE ERROR WAS NOT RESOLVED AND RESULT WAS NOT ACCESSIBLE. BIOMÉRIEUX CUSTOMER SERVICE RECOMMENDED CUSTOMER TO RESTART ANALYSIS OF THE TEST; THE RESULTS WERE DELAYED BY MORE THAN 24 HOURS. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S/USER'S STATE OF HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616303 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050002. One submission often covers many models, so check the product and lot details in each record.

• Z-1307-2021 · Jan 28, 2021 · Terminated
  VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short inc
• Z-0639-2019 · Nov 13, 2018 · Terminated
  VITEK 2 Systems Software Version 9.01 Update Kit.
• Z-3076-2017 · Jul 12, 2017 · Terminated
  VITEK 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for the identification (ID) and antimicrobial sus
• Z-3075-2017 · Jul 12, 2017 · Terminated
  VITEK 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and ye
• Z-0991-2013 · Feb 18, 2013 · Terminated
  VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models: (1) dc7100 8-port, Cat. #W0441; (2) dc7100 8-port (refurbished), Cat. #W0441R; (3) dc