API® NH 10400Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03573026035600), received between Oct 5, 2017 and Jun 29, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  INTENDED USE: API® NH IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF NEISSERIA, HAEMOPHILUS (AND RELATED GENERA) AND MORAXELLA CATARRHALIS (BRANHAMELLA CATARRHALIS). 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. API® NH ALSO ENABLES THE BIOTYPING OF HAEMOPHILUS INFLUENZAE AND HAEMOPHILUS PARAINFLUENZAE, AS WELL AS THE DETECTION OF A PENICILLINASE. DESCRIPTION OF THE ISSUE: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION OF HAEMOPHILUS INFLUENZAE ATCC® 49247¿ AS HAEMOPHILUS PARAINFLUANZAE DURING INTERNAL QUALITY CONTROL TESTING WITH API® NH, LOT 1008318370. THE CUSTOMER REPORTED THAT THE REPEAT TEST WITH API® NH, LOT 1008518850 WITH THE SAME STRAIN GAVE THE EXPECTED IDENTIFICATION. AS IT CONCERNS A QUALITY CONTROL, NO PATIENT IMPACT HAS BEEN REPORTED. TO BE NOTED THAT THE STRAIN USED BY THE CUSTOMER IS NOT INCLUDED IN THE ROUTINE QU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12083713 ↗
• MalfunctionFeb 15, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) REPORTED A NON CONFORMING QUALITY CONTROL STRAIN IN ASSOCIATION WITH THE API® NH (NEISSERIA GONORRHOEAE) TEST STRIP (LOT 100678088). THE CUSTOMER STATED THAT THEIR QC ORGANISM (HAEMOPHILUS INFLUENZAE ATCC® 10211) WAS CONFORMING ON A PREVIOUS LOT OF API TEST STRIPS, BUT NOT ON LOT 1006780880. THE CUSTOMER THEN TESTED A NEW ATCC® 10211 QC ORGANISM AND LOT 100678088 WAS NOT CONFORMING. THE CUSTOMER SWITCHED TO A DIFFERENT API NH LOT AND THE ISSUE WAS RESOLVED. THE ATCC® 10211 QC STRAIN IS USED TO PERFORM COMPREHENSIVE QUALITY CONTROL TO DEMONSTRATE POSITIVE AND NEGATIVE REACTIVITY WITH APNH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 8345218 ↗
• MalfunctionOct 5, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH API NH (REFERENCE 10400). THE CUSTOMER REPORTED THE EXPECTED IDENTIFICATION AS NEISSERIA SICCA AND THE ACTUAL RESULT WAS NEISSERIA GONORRHOEA 98% (GOOD ID). REPEAT TESTING CONFIRMED THE MISIDENTIFICATION. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6917592 ↗