API® 20 A 20300Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03573026048150), received between Oct 14, 2020 and Oct 27, 2021 — classified as 3 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 16, 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.

• MalfunctionOct 27, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  INTENDED USE: API® 20 A IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF ANAEROBES. 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. ISSUE DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION RESULT IN ASSOCIATION WITH THE PRODUCT API 20 A 25STRIPS+25MEDIA (REF. 20300, LOT 1008569360, EXPIRATION DATE = 10-JUL-2022) WHEN TESTING A CAP SURVEY STRAIN. THE CUSTOMER STATED LOT 1008569360 IDENTIFIED THE ISOLATE AS PREVOTELLA BIVIA, AND CONFIRMED THE EXPECTED RESULT FOR THE SURVEY STRAIN WAS PREVOTELLA MELANINOGENICA. THE CUSTOMER REPEATED TESTING AND THE SAME MISIDENTIFICATION RESULT WAS OBTAINED. BIOMÉRIEUX CUSTOMER SERVICE HAS REQUESTED THE CAP SURVEY STRAIN AS WELL AS CUSTOMER METHODOLOGY AND TROUBLESHOOTING INFORMATION. AS THERE IS NO PATIENT ASSOCIATED WITH THIS SURVEY STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. AN INVESTIGATION HAS BEEN PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12706289 ↗
• MalfunctionMay 24, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION RESULT IN ASSOCIATION WITH THE API® 20 A (REF. 20300, LOT 1008247410) WHEN TESTING A CAP SURVEY STRAIN. THE CUSTOMER STATED LOT 1008247410 IDENTIFIED THE ISOLATE AS PREVOTELLA BIVIA, AND CONFIRMED THE EXPECTED RESULT FOR THE SURVEY STRAIN WAS PREVOTELLA MELANINOGENICA. THE CUSTOMER REPEATED TESTING AND THE SAME MISIDENTIFICATION RESULT WAS OBTAINED. BIOMÉRIEUX CUSTOMER SERVICE HAS REQUESTED THE CAP SURVEY STRAIN AS WELL AS CUSTOMER METHODOLOGY AND TROUBLESHOOTING INFORMATION. AS THERE IS NO PATIENT ASSOCIATED WITH THIS SURVEY STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMERIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11873537 ↗
• MalfunctionOct 14, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF CLOSTRIDIUM BIFERMENTANS AS CLOSTRIDIUM PERFRINGENS WHILE TESTING AN EXTERNAL PROFICIENCY SURVEY SAMPLE WITH THE API® 20 A 25STRIPS+25MEDIA (REF 20300, LOT 1007917630). ACCORDING TO THE PROFICIENCY SURVEY REPORT, THE SAMPLE ACTUALLY CONTAINED CLOSTRIDIUM BIFERMENTANS AT A LEVEL OF 1950 CFU/G. THE PROFILE OBTAINED BY THE CUSTOMER WAS (B)(4) WHICH GAVE AN IDENTIFICATION OF CLOSTRIDIUM PERFRINGENS AT 99% EXCELLENT ID. AS THIS WAS AN EXTERNAL PROFICIENCY SURVEY SAMPLE, THERE IS NO PATIENT INVOLVED. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 10680336 ↗