API® 20 STREP 20600Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03573026048440), received between May 17, 2017 and May 27, 2021 — classified as 4 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2021False Positive Result; False Positive Result

  INTENDED USE: API® 20 STREP IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE GROUP OR SPECIES IDENTIFICATION OF MOST STREPTOCOCCI AND ENTEROCOCCI, AND THOSE MOST COMMON RELATED ORGANISMS. IT USES MINIATURIZED TESTS AS WELL AS 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 IN UNITED STATES NOTIFIED OF OBTAINING FALSE POSITIVE FOR ESCULIN FERRIC CITRATE (ESC) WHEN TESTING A QUALITY CONTROL STRAIN ; STREPTOCOCCUS EQUI SPP ZOOEPIDEMICUS ATCC® 700400¿ WITH THE API 20 STREP - REFERENCE 20600 - EXPIRATION DATE 21/09/2021. THE REACTION IN THE STRIP DOES NOT MATCH WITH A GOOD PATHOGEN PROFILE. THE TEST HAS BEEN PERFORMED THREE TIMES AND FALSE POSITIVE FOR ESC HAS BEEN OBTAINED EACH TIME. AS IT CONCERNS A QUALITY CONTROL TEST, NO PATIENT IMPACT HAS BEEN REPORTED AS A CONSEQUENCE OF THIS FALSE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895173 ↗
• MalfunctionNov 8, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF INCORRECT WELL REACTIONS FOR HIPPURIC ACID (HIP), BETA-GALACTOSIDASE (BGAL), AND PEPTIDOGLYCAN-ASSOCIATED LIPOPROTEIN (PAL) FOR AN EXTERNAL QC STREPTOCOCCUS DYSGALACTIAE STRAIN USING API 20 STREP 25STRIPS+25MEDIA STRIPS (REFERENCE (B)(4)). THE RESULTS THE CUSTOMER OBTAINED WERE CONSISTENT WITH AEROCOCCUS URINAE NOT STREPTOCOCCUS DYSGALACTIAE. BIOMERIEUX CUSTOMER SERVICE REQUESTED ADDITIONAL INFORMATION ABOUT THIS EVENT INCLUDING LOT NUMBER AND SAMPLE PREPARATION TECHNIQUE. ADDITIONALLY, CUSTOMER SERVICE RECOMMENDED TO PERFORM QC TESTED USING ISOLATES THAT ARE LISTED IN THE API 20 STREP 25STRIPS+25MEDIA PACKAGE INSERT. AT THE TIME OF THIS ASSESSMENT NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMERIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Patient Involvement

  MAUDE report 9296602 ↗
• MalfunctionNov 19, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) REPORTED A MISIDENTIFICATION OF AN ENTEROCOCCUS GALLINARUM SURVEY SAMPLE (CQE ECBU 2018-3A PROSPECTIVE BIOLOGY 11.1646 ) AS ENTEROCOCCUS FAECIUM IN ASSOCIATION WITH THE API® STREP TEST STRIP. THE CUSTOMER REPEATED THE TEST SEVERAL TIMES WITH SEVERAL LOTS AND FROM DIFFERENT CULTURE MEDIA, AND OBTAINED THE SAME RESULT. THE QUALITY CONTROL WAS CONFORMING. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT PERTAINED TO A SURVEY SAMPLE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 8087036 ↗
• MalfunctionMay 17, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH API® 20 STREP. THE CUSTOMER REPORTED THAT THE API® 20 STREP TEST GAVE A FALSE IDENTIFICATION. THE FALSE IDENTIFICATION OF AEROCOCCUS VIRIDANS WAS REPORTED TO THE CLINICIAN. THERE WAS NO INJURY TO PATIENT DUE TO THE FALSE IDENTIFICATION, HOWEVER THERE WAS A DELAY GREATER THAN 24 HOURS BECAUSE THE FIRST IDENTIFICATION WAS PERFORMED ON VITEK® MS AND THEN SUBSEQUENT TESTING ON THE API® 20 STREP STRIP. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6572875 ↗