CHROMID® CPS® Elite Agar (CPSO)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03573026600402), received between Jul 25, 2019 and Jul 3, 2025 — classified as 5 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 18, 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 3, 2025False Negative Result; False Negative Result

  INTENDED USE: ISOLATION, ENUMERATION, AND DIRECT OR PRESUMPTIVE IDENTIFICATION OF URINARY TRACT INFECTION ORGANISMS. THIS MEDIUM IS AN ISOLATION, ENUMERATION, AND IDENTIFICATION MEDIUM FOR URINE SPECIMENS. THIS MEDIUM ENABLES: THE MICROBIAL ENUMERATION OF THE SPECIMEN BY MEANS OF STANDARDIZED INOCULATION METHODS. THE DIRECT IDENTIFICATION OF ESCHERICHIA COLI. THE PRESUMPTIVE IDENTIFICATION OF THE FOLLOWING BACTERIAL SPECIES OR GENERA:1, 2 ENTEROCOCCUS; KLEBSIELLA, ENTEROBACTER, SERRATIA, CITROBACTER (KESC); PROTEUS, MORGANELLA, PROVIDENCIA (PMP). ISSUE DESCRIPTION: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF NO CHARACTERISTIC COLOR WITH KLEBSIELLA PNEUMONIAE STRAIN (URINE SAMPLE) IN ASSOCIATION WITH CHROMID CPS ELITE OPAQUE 100PL (REF. 416173, LOT 1011288120, EXP DATE. 10-AUG-2025) THE CUSTOMER STATED THAT HE HAD KLEBSIELLA STRAIN WITH PINK COLOR IN ASSOCIATION WITH CHROMID CPS ELITE OPAQUE 100PL (REF. 416173). NOTE: AS CHROMID CPS ELITE OPAQUE 100P (REF. 416173) IS FOR THE DIRECT IDENTIFICATION OF ESCHERICHIA COLI, RED TO BURGUNDY COLONIES ARE IDENTIFIED AS E.COLI WITHOUT ADDITIONAL TESTS . AND SPONTANEOUS BLUE TO GREEN COLORATION OF STRAINS INDICATED THE PRESENCE OF KESC (KLEBSIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22392785 ↗
• MalfunctionAug 18, 2022False Negative Result; False Negative Result

  INTENDED USE: ISOLATION, ENUMERATION, AND DIRECT OR PRESUMPTIVE IDENTIFICATION OF URINARY TRACT INFECTION ORGANISMS. THIS MEDIUM IS AN ISOLATION, ENUMERATION, AND IDENTIFICATION MEDIUM FOR URINE SPECIMENS. THIS MEDIUM ENABLES: ¿ THE MICROBIAL ENUMERATION OF THE SPECIMEN BY MEANS OF STANDARDIZED INOCULATION METHODS. ¿ THE DIRECT IDENTIFICATION OF ESCHERICHIA COLI. ¿ THE PRESUMPTIVE IDENTIFICATION OF THE FOLLOWING BACTERIAL SPECIES OR GENERA:1, 2 ¿ ENTEROCOCCUS; ¿ KLEBSIELLA, ENTEROBACTER, SERRATIA, CITROBACTER (KESC); ¿ PROTEUS, MORGANELLA, PROVIDENCIA (PMP). DESCRIPTION: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF OBTAINING AN INCORRECT COLONY COLORATION FOR TWO ENTEROBACTER CLOACAE ISOLATES IN ASSOCIATION WITH THE CHROMID CPS ELITE OPAQUE (REF 418206, LOT 1009413080, EXPIRY DATE 26-SEP-2022). THE CUSTOMER REPORTED THAT THE ISOLATES GREW PINK COLONIES AT 24 HOURS THAT THEN TURNED BLUE OR BLUE/PURPLE AT 48 HOURS. BASED ON THE COLORATION AT 24 HOURS, THE CUSTOMER EXPECTED THE IDENTIFICATIONS TO BE ESCHERICHIA COLI. IDENTIFICATION TESTING WAS PERFORMED AFTER THE CUSTOMER NOTICED THAT THE COLONY COLORATION HAD CHANGED FROM PINK TO BLUISH AND THE ISOLATES WERE BOTH IDENTIFIED AS ENTEROB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15253863 ↗
• MalfunctionApr 6, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CHROMID® CPS® ELITE AGAR IS AN ISOLATION, ENUMERATION AND IDENTIFICATION MEDIUM FOR URINE SPECIMENS. IT ENABLES: THE MICROBIAL ENUMERATION OF THE SPECIMEN BY MEANS OF STANDARDIZED INOCULATION METHODS. THE DIRECT IDENTIFICATION OF ESCHERICHIA COLI AND THE PRESUMPTIVE IDENTIFICATION OF THE FOLLOWING BACTERIAL SPECIES OR GENERA : ENTEROCOCCUS, KLEBSIELLA, ENTEROBACTER, SERRATIA, CITROBACTER (KESC), PROTEUS, PROVIDENCIA, MORGANELLA (PROTEEAE). ISSUE DESCRIPTION: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF DISCREPANT IDENTIFICATION FOR AN URINE SAMPLE WITH E.COLI STRAIN IN ASSOCIATION WITH CHROMID CPS ELITE OPAQUE 20 PT (REF. 418206, LOT UNKNOWN). THE CUSTOMER STATED THAT HE HAD DISCREPANT RESULTS BETWEEN : CPSO AND VITEK® MS FOR AN URINE CULTURE SAMPLE. RESULT SUMMARY: *CPSO PLATE: SHOWED BLUE COLONIES, INDICATING KESC (KLEBSIELLA, ENTEROBACTER, SERRATIA AND CITROBACTER). E. COLI SHOULD RESULT IN RED TO BURGUNDY COLORATION. *VITEK MS : E. COLI STRAIN (IDENTIFICATION 99.9%). THE CUSTOMER INFORMED BIOMÉRIEUX CUSTOMER SERVICE THAT NO DELAY IN THE RESULT AND NO PATIENT IMPACT WERE OBSERVED. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14019869 ↗
• MalfunctionJul 25, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A POTENTIAL SPECIFICITY ISSUE ASSOCIATED WITH CHROMID CPS ELITE OPAQUE AGAR (REF. 418206, LOT. #1007230410, EXP. DATE: 22-JUL-2019). THE CUSTOMER STATED HAVING OBTAINED PINK COLONIES FOR AN ENTEROBACTER CLOACAE STRAIN. PINK COLONIES ON THIS MEDIUM ARE TO INDICATE ESCHERICHIA COLI SPECIES. THE STRAIN WAS CONFIRMED AS ENTEROBACTER CLOACAE SPECIES BY MASS SPECTROMETRY. THE FOLLOWING LIMITATION IS INCLUDED IN THE ASSOCIATED INSTRUCTIONS FOR USE (IFU): "CERTAIN SPECIES MAY PRODUCE COLONIES OF THE SAME CHARACTERISTIC COLOR AS E. COLI (EX: CITROBACTER)." SOME ENTEROBACTER CLOACAE COULD HAVE BETA-GLUCURONIDASE ACTIVITY (OR BETA-GALACTOSIDASE) THAT COULD LEAD TO PINK COLONIES. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8826235 ↗
• MalfunctionJul 25, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A POTENTIAL SPECIFICITY ISSUE ASSOCIATED WITH CHROMID CPS ELITE OPAQUE AGAR (REF. 418206, LOT. #1007274960, EXP. DATE: 08-AUG-2019). THE CUSTOMER STATED HAVING OBTAINED PINK COLONIES FOR AN ENTEROBACTER CLOACAE STRAIN. PINK COLONIES ON THIS MEDIUM ARE TO INDICATE ESCHERICHIA COLI SPECIES. THE STRAIN WAS CONFIRMED AS ENTEROBACTER CLOACAE SPECIES BY MASS SPECTROMETRY. THE FOLLOWING LIMITATION IS INCLUDED IN THE ASSOCIATED INSTRUCTIONS FOR USE (IFU): "CERTAIN SPECIES MAY PRODUCE COLONIES OF THE SAME CHARACTERISTIC COLOR AS E. COLI (EX: CITROBACTER)." SOME ENTEROBACTER CLOACAE COULD HAVE BETA-GLUCURONIDASE ACTIVITY (OR BETA-GALACTOSIDASE) THAT COULD LEAD TO PINK COLONIES. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8826233 ↗