API® 20 NE 20050Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03573026047702), received between Feb 15, 2018 and Apr 24, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2023Incorrect Measurement; Incorrect Measurement

  PRODUCT DESCRIPTION API® 20 NE IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF NON-FASTIDIOUS, NON-ENTERIC GRAM-NEGATIVE RODS (FOR EXAMPLE, PSEUDOMONAS, ACINETOBACTER, MORAXELLA, VIBRIO, AEROMONAS). IT USES MINIATURIZED TESTS AS WELL AS A SPECIALLY ADAPTED DATABASE. INOCULATION AND READING OF THE STRIP ARE PERFORMED MANUALLY AND THE IDENTIFICATION IS OBTAINED USING AN IDENTIFICATION SOFTWARE. THE COMPLETE LIST OF THOSE ORGANISMS THAT IT IS POSSIBLE TO IDENTIFY WITH THIS SYSTEM IS GIVEN IN THE TECHNICAL BROCHURE. INFORMATION FOR IDENTIFICATION SOFTWARE. COMPLAINT DESCRIPTION AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A SCIENTIFIC PUBLICATION (PUBLICATION 293705000 BA 20050) ENTITLED: "MORPHOLOGY, BIOCHEMICAL, AND MOLECULAR CHARACTERIZATION OF PASTEURELLA MULTOCIDA CAUSING HEMORRHAGIC SEPTICEMIA IN INDONESIA". BIOMÉRIEUX R&D AND MEDICAL AFFAIRS HAVE REVIEWED THE PUBLICATION. THIS STUDY DESCRIBES THE IDENTIFICATION OF TEN (10) ISOLATES OF PASTEURELLA MULTOCIDA CAUSING SEVERE ILLNESS IN INDONESIAN LIVESTOCK. API 20NE WAS COMPARED TO TRADITIONAL BIOCHEMICAL TECHNIQUES AND MOLECULAR TECHNIQUES. EIGHT OUT OF TEN ISOLATES WERE CORRECTLY IDENTIFIED AS P. MULTOC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16793829 ↗
• MalfunctionDec 16, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF RALSTONIA MANNITOLYLITICA AS PSEUDOMONAS FLUORESCENS IN ASSOCIATION WITH THE PRODUCT API 20 NE (REF. 20050, BATCH NOT REPORTED, EXPIRY DATE UNKNOWN). CUSTOMER REPORTED THAT THEY HAVE OBTAINED DISCREPANT RESULTS BETWEEN TWO METHODS. API® 20 NE AND PCR, AS FOLLOWS: API 20 NE RESULT = PSEUDOMONAS FLUORESCENS, PCR RESULT = RALSTONIA MANNITOLYLITICA. 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 WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019848 ↗
• MalfunctionNov 10, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  INTENDED USE: API® 20 NE IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF NON-FASTIDIOUS, NON-ENTERIC GRAM-NEGATIVE RODS (FOR EXAMPLE, PSEUDOMONAS, ACINETOBACTER, MORAXELLA, VIBRIO, AEROMONAS). IT USES MINIATURIZED TESTS AS WELL AS A SPECIALLY ADAPTED DATABASE. INOCULATION AND READING OF THE STRIP ARE PERFORMED MANUALLY AND THE IDENTIFICATION IS OBTAINED USING AN IDENTIFICATION SOFTWARE. DESCRIPTION: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION OF SPHINGOMONAS PAUCIMOBILIS AS BURKHOLDERIA CEPACIA IN ASSOCIATION WITH THE API® 20 NE 25STRIPS+25MEDIA (REF 20050). NO LOT NUMBERS HAVE BEEN PROVIDED BY THE CUSTOMER. THE CUSTOMER REPORTED OBTAINING AN IDENTIFICATION OF BURKHOLDERIA CEPACIA WITH THE API 20 NE. THE STRAIN WAS THEN SENT TO AN EXTERNAL LABORATORY WHERE IT WAS IDENTIFIED AS SPHINGOMONAS PAUCIMOBILIS BY VITEK® MS. API 20 NE: BURKHOLDERIA CEPACIA. VITEK MS: SPHINGOMONAS PAUCIMOBILIS. GLOBAL CUSTOMER SERVICE (GCS) REVIEWED TROUBLESHOOTING INFORMATION PROVIDED BY THE CUSTOMER AND IDENTIFIED THAT THE CUSTOMER IS INCUBATING THE STRIPS AT 30 - 35 °C WHILE THE INSTRUCTIONS FOR USE REQUIRE A TEMPERATURE OF 29 °C ± 2 °C (27 - 31 °C). ADDITIONAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787562 ↗
• MalfunctionNov 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  INTENDED USE: API® 20 NE IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF NON-FASTIDIOUS, NON-ENTERIC GRAM-NEGATIVE RODS (FOR EXAMPLE, PSEUDOMONAS, ACINETOBACTER, MORAXELLA, VIBRIO, AEROMONAS). IT USES MINIATURIZED TESTS AS WELL AS A SPECIALLY ADAPTED DATABASE. INOCULATION AND READING OF THE STRIP ARE PERFORMED MANUALLY AND THE IDENTIFICATION IS OBTAINED USING AN IDENTIFICATION SOFTWARE. INCIDENT DESCRIPTION: A CUSTOMER IN SINGAPORE REPORTED TO BIOMÉRIEUX A QC FAILURE IN ASSOCIATION WITH THE PRODUCT API 20 NE (REF. 20050, BATCH 1008507370, EXPIRY DATE 14-JAN-2022) WITH A QC STRAIN. THE CUSTOMER HAS TESTED AEROMONAS HYDROPHILIA ATCC® 35654¿ WITH API 20 NE. IT WAS REPORTED THE USER ATTEMPTED QC THREE TIMES; HOWEVER, ALL THREE TESTS FAILED ON NO3, TRP, GLU, ADH, URE, ESC, AND GEL. THE CUSTOMER TESTED THE QC STRAIN USING VITEK 2 GN ID CARD, AND IT PROVED AS A. HYDROPHILIA WITH INTENDED POSITIVE BIOCHEMICAL REACTIONS. MANUAL NITRATE TEST HAS BEEN PERFORMED WITH THE QC STRAIN, AND CONFIRMED POSITIVITY. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QC STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. AN INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760583 ↗
• MalfunctionAug 19, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PRODUCT INTENDED USE: API® 20 NE IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF NON-FASTIDIOUS, NON-ENTERIC GRAM-NEGATIVE RODS (FOR EXAMPLE, PSEUDOMONAS, ACINETOBACTER, MORAXELLA, VIBRIO, AEROMONAS). IT USES MINIATURIZED TESTS AS WELL AS A SPECIALLY ADAPTED DATABASE. INOCULATION AND READING OF THE STRIP ARE PERFORMED MANUALLY AND THE IDENTIFICATION IS OBTAINED USING AN IDENTIFICATION SOFTWARE. DESCRIPTION OF THE ISSUE: A CUSTOMER FROM (B)(6) REPORTED THAT HE OBTAINED A MISIDENTIFICATION OF PSEUDOMONAS FRAGI AS PSEUDOMONAS PUTIDA WHEN USING API 20 NE STRIP (REF. (B)(4)) ¿ LOT 1008507190. THE CUSTOMER REPORTED HE IDENTIFIED A STRAIN WITH API, MALDI (BRUKER) AND PCR AND HE OBTAINED THE FOLLOWING RESULTS: API 20 NE: PSEUDOMONAS PUTIDA (99.1%, AFTER 24 AND 48H), MALDI AND PCR: PSEUDOMONAS FRAGI. TO BE NOTED THAT PSEUDOMONAS FRAGI IS NOT INCLUDED IN THE API DATABASE. THERE IS NO INDICATION FROM THE CUSTOMER THAT THIS ISSUE LED TO A DELAY OF RESULT OR IMPACTED THE PATIENT STATE OF HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12342699 ↗
• MalfunctionDec 19, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) REPORTED A MISIDENTIFICATION IN ASSOCIATION WITH THE API® 20 NE (NON-ENTEROBACTERIACEAE) TEST STRIPS (LOT 1006179400). THE CUSTOMER TESTED THE STRAIN FROM A 24 HOUR CULTURE ON TSA, WITH THE API NE, AND THE INITIAL IDENTIFICATION WAS PSEUDOMONAS CEPACIA (68.9%). THE CUSTOMER REPEATED THE TEST WITH AN INCUBATION OF 48 HOURS AT 33 ° C, AND OBTAINED PSEUDOMONAS FLUORESCENS (97.2%). THE CUSTOMER SENT THE STRAIN TO ANOTHER LABORATORY FOR PCR AND THE RESULT WAS PSEUDOMONAS CHLORORAPHIS. NO PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT 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 8179424 ↗
• MalfunctionFeb 15, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) REPORTED TO BIOMÉRIEUX MISIDENTIFICATION ASSOCIATED WITH API® 20 NE. THE CUSTOMER REPORTED THE EXPECTED IDENTIFICATION TO BE BURKHOLDERIA CEPACIA BUT THE ACTUAL RESULT WAS PSEUDOMONAS AERUGINOSA. SAMPLES WERE SENT TO ANOTHER SITE FOR REPEAT TESTING USING MALDI AND THE RESULT WAS P.AERUGINOSA. THE INCORRECT RESULT WAS REPORTED TO THE PHYSICIAN. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7274425 ↗