RAPID ID 32 STREPRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03573026588625), received between Apr 20, 2018 and Jul 24, 2024 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2024Incorrect Measurement; Incorrect Measurement

  INTENDED USE: RAPID ID 32 STREP IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF STREPTOCOCCI AND ENTEROCOCCI, AND THOSE MOST COMMON RELATED ORGANISMS, IN FOUR HOURS. IT USES MINIATURIZED TESTS AS WELL AS A SPECIFICALLY ADAPTED DATABASE. AFTER MANUAL INOCULATION OF THE STRIP, READING CAN BE PERFORMED EITHER AUTOMATICALLY OR MANUALLY AND THE IDENTIFICATION IS OBTAINED USING AN IDENTIFICATION SOFTWARE. ISSUE DESCRIPTION: A CUSTOMER IN JAPAN NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF ENTEROCOCCUS FAECIUM AS ENTEROCOCCUS GALLINARUM ASSOCIATED WITH RAPID ID 32 STREP (B)(4) - REF. 32600, LOT UNKNOWN. SUMMARY: RAPID ID 32 STREP: ENTEROCOCCUS GALLINARUM. WALKAWAY: ENTEROCOCCUS FAECIUM. MASS SPECTROMETER (MANUFACTURER UNKNOWN): ENTEROCOCCUS FAECIUM. AT THE TIME OF THE GLOBAL ASSESSMENT, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19816913 ↗
• MalfunctionNov 10, 2023Unable to Obtain Readings; Unable to Obtain Readings

  INTENDED USE: RAPID ID 32 STREP IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF STREPTOCOCCI AND ENTEROCOCCI, AND THOSE MOST COMMON RELATED ORGANISMS, IN FOUR HOURS. IT USES MINIATURIZED TESTS AS WELL AS A SPECIFICALLY ADAPTED DATABASE. AFTER MANUAL INOCULATION OF THE STRIP, READING CAN BE PERFORMED EITHER AUTOMATICALLY OR MANUALLY AND THE IDENTIFICATION IS OBTAINED USING AN IDENTIFICATION SOFTWARE. ISSUE DESCRIPTION: A CUSTOMER IN JAPAN NOTIFIED BIOMÉRIEUX THAT THEY OBSERVED "STRANGE POSITIVE REACTIONS" WHILE TESTING A PATIENT STREPTOCOCCUS DYSGALACTIAE SSP. EQUISIMILIS STRAIN WITH THE RAPID ID 32 STREP (REF 32600, LOT 1009964540). THE CUSTOMER REPORTED THAT THEY TESTED THE S. DYSGALACTIAE SSP. EQUISIMILIS STRAIN RANDOMLY NINE (9) TIMES, AND DURING THREE (3) OF THE TESTS THE ENTIRE TOP ROW OF THE TEST KIT TURNED RED. THE CUSTOMER PROVIDED RESULTS FROM SEVEN (7) TESTS INCLUDING 4 UNACCEPTABLE PROFILES AND 3 GOOD PROFILES. THERE IS NO EVIDENCE OF A MISIDENTIFICATION. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO OR CONTRIBUTED TO DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18111107 ↗
• MalfunctionMar 19, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A VETERINARY CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION OF A KNOWN STRAIN OF STREPTOCOCCUS UBERIS OBTAINED AS STREPTOCOCCUS ORALIS WHILE USING THE API® RAPID ID 32 STREP 25 STRIPS (REFERENCE # 32600, LOT # 1008262780). THE TEST WAS REPEATED FOUR (4) TIMES WITH THE SAME STRAIN BY TWO DIFFERENT TECHNICIANS. EACH TIME, STREPTOCOCCUS ORALIS HAS BEEN IDENTIFIED INSTEAD OF STREPTOCOCCUS UBERIS. THE CUSTOMER DID NOT PERFORM QC STRAIN TESTING AS RECOMMENDED BY THE PACKAGE INSERT. IT IS NOT KNOWN IF THE CUSTOMER USED A PATIENT STRAIN OR A QUALITY CONTROL STRAIN. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT IMPACT. LOCAL CUSTOMER SERVICE (LCS) CALLED THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION AND THE CUSTOMER STATED THEY RETESTED AND THE STRIPS ARE NOW WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11532107 ↗
• MalfunctionNov 22, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION RESULTS WHEN TESTING A PATIENT STRAIN WITH THE API® RAPID ID 32 STREP (REF. 32600, LOT # NOT SPECIFIED). THE PATIENT STRAIN WAS ISOLATED FROM A SAMPLE OF LIQUID FROM A PUNCTURED DIGESTIVE ORGAN. API® RAPID ID 32 STREP RETURNED A VERY GOOD IDENTIFICATION RESULT TO "STREPTOCOCCUS DYSGALACTIAE SSP DYSGALACTIAE (99.9%), NEXT TAXON STREPTOCOCCUS DYSGALACTIAE SSP EQUISIMILIS (0.1%)." THE FINAL ORGANISM IDENTIFICATION WAS DETERMINED VIA 16S RRNA SEQUENCING AS STREPTOCOCCUS DYSGALACTIAE SSP EQUISIMILIS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9366010 ↗
• MalfunctionApr 20, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT THE OCCURRENCE OF MISIDENTIFICATION OF ENTEROCOCCUS FAECIUM AS ENTEROCOCCUS GALLINARUM IN ASSOCIATION WITH THE API® RAPID ID 32 STREP TEST. THE CUSTOMER STATED THAT TESTING VIA API® 20 STREP, VITEK® MS AND VITEK® 2 OBTAINED THE EXPECTED RESULT OF ENTEROCOCCUS FAECIUM. THERE WAS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. CULTURE SUBMITTAL WAS REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7447656 ↗