BD Phoenix™ YEAST ID 448316Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00382904483166), received between Mar 8, 2022 and Jul 22, 2025 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (23 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 29, 2024Class IIOpen, Classified

   Esculin, a substrate used in other panels and normally in A16 well, was found in A17 well. A17 in yeast panels is supposed to be an empty well and is not a part of the normal ID evaluation. However, A17 is checked for fluorescence and if anything is found, the system will abort the panel with the message Fluorescent interference has been detected. Esculin is expected to trigger this fluorescence and test cancellation.

   Z-1399-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD PHOENIX¿ YEAST ID, A PATIENT SPECIMEN OF C. AURIS WAS MISIDENTIFIED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22565160 ↗
• MalfunctionJun 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ YEAST ID A PATIENT ISOLATE (NAKASEOMYCES GLABRATUS PREVIOUSLY KNOWN AS CANDIDA GLABRATA) WAS MISIDENTIFIED AS PICHIA FERMENTANS PREVIOUSLY KNOWN AS CANDIDA FIRMETARIA. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22365386 ↗
• MalfunctionJun 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ YEAST ID A PATIENT ISOLATE (CANDIDA PARAPSILOSIS) WAS MISIDENTIFIED AS CANDIDA ALBICANS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22364788 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ YEAST ID A PATIENT ISOLATE (TRICHOSPORON INKIN) WAS MISIDENTIFIED AS PAPILIOTREMA LAURENTII. THE FINAL RESULT WAS VERIFIED USING MALDI. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337537 ↗
• MalfunctionJun 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ YEAST ID A PATIENT ISOLATE (CRYPTOCOCCUS GATTII) WAS MISIDENTIFIED AS CRYPTOCOCCUS NEOFORMANS. THE FINAL RESULT WAS VERIFIED USING MALDI. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337535 ↗
• MalfunctionJan 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ YEAST ID A PATIENT ISOLATE WAS MISIDENTIFIED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264282 ↗
• MalfunctionApr 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD PHOENIX¿ YEAST ID, A PATIENT ISOLATE WAS MISIDENTIFIED AS CRYPTOCOCCUS NEOFORMANS. THE BACTERIAL CULTURE AND GRAM STAIN DID NOT MATCH THE MORPHOLOGY FOR THE RESULTS GIVEN. THE RESULT WAS VERIFIED USING THE MALDI, GIVING THE RESULT CANDIDA PSEUDOHAEMULONII. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197123 ↗
• MalfunctionJan 22, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH THE BD PHOENIX¿ YEAST ID, A SAMPLE OF LODDEROMYCES ELONGISPORUS WAS MISIDENTIFIED AS CRYPTOCOCCUS LUTEOLUS. CONFIRMATORY TESTING WAS DONE ON MALDI. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552435 ↗
• MalfunctionJun 27, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH THE BD PHOENIX¿ YEAST ID, TWO FALSE RESULTS WERE OBTAINED FOR THE SAME PATIENT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6), A C. AURIS STRAIN WAS ISOLATED FROM A PATIENT URINE SPECIMEN. THIS ISOLATE WAS CORRECTLY IDENTIFIED BY THE PHOENIX AS C. AURIS/HAEMULONII WITH A SPECIAL MESSAGE. THE CUSTOMER LATER REPORTED OBTAINING DIFFERENT IDS WHEN SCREENING THE PATIENT FROM URINE, NOSE AND SKIN SPECIMENS. SOME OF THE PATIENT ISOLATES WERE MISIDENTIFIED ON THE PHOENIX AS PROTOTHECA WICHERHAMII (REPEAT ON PHOENIX: CANDIDA PARAPSILOSIS) AND CANDIDA ALBICANS (REPEAT ON PHOENIX: CANDIDA ALBICANS). THESE ISOLATES WERE SENT TO THE PUBLIC HEALTH LAB (LSPQ) AND WERE IDENTIFIED AS CANDIDA AURIS ON THE MALDI. SPECIMEN V7050319: ISOLATE 1: IDENTIFIED AS PROTOTHECA WICKERHAMII ON PHOENIX, SLOPE SENT FOR MALDI ANALYSIS, ID: CANDIDA AURIS. ISOLATE 2: THE CUSTOMER RESUBBED ISOLATE 1 FROM CRYO TWICE AND ANALYZED ON THE PHOENIX. ISOLATE 2 WAS IDENTIFIED AS CANDIDA PARAPSILOSIS. SPECIMEN V7260588: ISOLATE 1: IDENTIFIED AS CANDIDA ALBICANS ON PHOENIX BUT THE CANDIDA ALBICANS SCREENING TEST WAS NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17209962 ↗
• MalfunctionMay 16, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD PHOENIX¿ YEAST ID WRONG IDS WERE OBTAINED WHEN TESTING A PANEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A C. AURIS STRAIN ISOLATED FROM A URINE WAS MIS-IDENTIFIED AS C. AURIS/HAEMULONII. THE STRAIN WAS LATER SENT TO LSPQ FOR FULL IDENTIFICATION AND WGS AND WAS CONFIRMED AS C. AURIS. FOLLOWING THE DISCOVERY OF THAT C. AURIS CASE, A DIVERSE PANEL OF 13 C. AURIS ISOLATES (REPRESENTING THE 5 CLADES) WAS SENT TO THE HOSPITAL TO ASSESS ID PERFORMANCE. OF THE 13 STRAINS TESTED, 11 RETURNED C. AURIS/HAEMULONII AND 2 C. PARAPSILOSIS (SEE ATTACHED TABLE). THE C. PARAPSILOSIS REPEATED, AND YIELDED SAME ID RESULT. THE C. HAEMULONII MIS-ID IS NOT SURPRISING AS PREVIOUSLY REPORTED, BUT C. PARAPSILOSIS MIS-ID NOT DOCUMENTED IN THE LITERATURE. BOTH MIS-ID WERE OBTAINED WITH CLADE II ISOLATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16942572 ↗
• MalfunctionMar 30, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ YEAST ID THERE WERE 3 OCCURRENCES OF MISIDENTIFICATION OF THE MICROORGANISM CANDIDA AURIS RELATED TO THE INSTRUMENT BDPHOENIX THAT WOULD HAVE IDENTIFIED THE FUNGUS AS C. PARAPSILOSIS. THE MISIDENTIFICATION WAS CONFIRMED BY GENETIC SEQUENCING. NO PATIENT IMPACT WAS REPORTED. THIS IS THE 2ND OF 2 OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIPTION: MISIDENTIFICATION OF THE MICROORGANISM CANDIDA AURIS, RELATED TO THE INSTRUMENT BDPHOENIX THAT WOULD HAVE IDENTIFIED THE FUNGUS AS C. PARAPSILOSIS. THE MISIDENTIFICATION WAS CONFIRMED BY GENETIC SEQUENCING AT THE LABORATÓRIO ESPECIAL DE MICOLOGIA DA LEMI/UNIFESP/SP, WHICH IS THE REFERENCE FOR SEQUENCING CANDIDA AURIS SAMPLES/ISOLATES FROM BRAZILIAN OUTBREAKS. THE STATE OF PERNAMBUCO HAS BEEN FACING A CANDIDA AURIS OUTBREAK SINCE (B)(6) 2022. CANDIDA AURIS IS AN EMERGING FUNGUS THAT POSES A SERIOUS THREAT TO GLOBAL HEALTH BECAUSE IT CAN CAUSE INVASIVE INFECTIONS, WHICH ARE ASSOCIATED WITH HIGH MORTALITY, CAN BE MULTIRESISTANT, AND CAN LEAD TO OUTBREAKS IN HEALTHCARE FACILITIES. THE POTENTIAL MISIDENTIFICATION OF C. AURIS CASES (GENERATING FALSE NEGATIVE RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16642864 ↗
• MalfunctionMar 3, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PATIENT 3 OF 6. IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ YEAST ID THAT THERE WAS MISIDENTIFICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT 1 (PR# 6251104) : LABORATORY 1 L.P. - 6 PATIENT SAMPLES - OCCURRENCE JUL/22 - SKU 448316 - BATCH 1236938 - ISSUE MIS-ID. DESCRIPTION: MISIDENTIFICATION OF THE MICROORGANISM CANDIDA AURIS, RELATED TO THE INSTRUMENT BDPHOENIX THAT WOULD HAVE IDENTIFIED THE FUNGUS AS C. PARAPSILOSIS. THE MISIDENTIFICATION WAS CONFIRMED BY GENETIC SEQUENCING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16481774 ↗
• MalfunctionMar 3, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PATIENT 5 OF 6. IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ YEAST ID THAT THERE WAS MISIDENTIFICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT 1 (PR# 6251104) : LABORATORY 1 L.P. - 6 PATIENT SAMPLES - OCCURRENCE JUL/22 - SKU 448316 - BATCH 1236938 - ISSUE MIS-ID. DESCRIPTION: MISIDENTIFICATION OF THE MICROORGANISM CANDIDA AURIS, RELATED TO THE INSTRUMENT BDPHOENIX THAT WOULD HAVE IDENTIFIED THE FUNGUS AS C. PARAPSILOSIS. THE MISIDENTIFICATION WAS CONFIRMED BY GENETIC SEQUENCING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16481772 ↗
• MalfunctionMar 3, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PATIENT 6 OF 6 IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ YEAST ID THAT THERE WAS MISIDENTIFICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT 1 (PR# 6251104) : LABORATORY 1 L.P. - 6 PATIENT SAMPLES - OCCURRENCE JUL/22 - SKU 448316 - BATCH 1236938 - ISSUE MIS-ID DESCRIPTION: MISIDENTIFICATION OF THE MICROORGANISM CANDIDA AURIS, RELATED TO THE INSTRUMENT BDPHOENIX THAT WOULD HAVE IDENTIFIED THE FUNGUS AS C. PARAPSILOSIS. THE MISIDENTIFICATION WAS CONFIRMED BY GENETIC SEQUENCING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16481754 ↗
• MalfunctionMar 3, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PATIENT 4 OF 6. IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ YEAST ID THAT THERE WAS MISIDENTIFICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT 1 (PR# 6251104) : LABORATORY 1 L.P. - 6 PATIENT SAMPLES - OCCURRENCE JUL/22 - SKU 448316 - BATCH 1236938 - ISSUE MIS-ID. DESCRIPTION: MISIDENTIFICATION OF THE MICROORGANISM CANDIDA AURIS, RELATED TO THE INSTRUMENT BDPHOENIX THAT WOULD HAVE IDENTIFIED THE FUNGUS AS C. PARAPSILOSIS. THE MISIDENTIFICATION WAS CONFIRMED BY GENETIC SEQUENCING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16481710 ↗
• MalfunctionMar 3, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PATIENT 2 OF 6. IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ YEAST ID THAT THERE WAS MISIDENTIFICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT 1 (PR# (B)(4)) : LABORATORY 1 L.P. - 6 PATIENT SAMPLES - OCCURRENCE (B)(6) 2022 - SKU 448316 - BATCH 1236938 - ISSUE MIS-ID. DESCRIPTION: MISIDENTIFICATION OF THE MICROORGANISM CANDIDA AURIS, RELATED TO THE INSTRUMENT BDPHOENIX THAT WOULD HAVE IDENTIFIED THE FUNGUS AS C. PARAPSILOSIS. THE MISIDENTIFICATION WAS CONFIRMED BY GENETIC SEQUENCING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16481703 ↗
• MalfunctionMar 2, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PATIENT 1 OF 6. IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ YEAST ID THAT THERE WAS MISIDENTIFICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT 1 (PR# 6251104) : LABORATORY 1 L.P. - 6 PATIENT SAMPLES - OCCURRENCE JUL/22 - SKU 448316 - BATCH 1236938 - ISSUE MIS-ID. DESCRIPTION: MISIDENTIFICATION OF THE MICROORGANISM CANDIDA AURIS, RELATED TO THE INSTRUMENT BDPHOENIX THAT WOULD HAVE IDENTIFIED THE FUNGUS AS C. PARAPSILOSIS. THE MISIDENTIFICATION WAS CONFIRMED BY GENETIC SEQUENCING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475794 ↗
• MalfunctionJan 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD PHOENIX¿ YEAST ID MIS IDENTIFICATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE COLONY PROPERTIES OF THE MEDIUM AND THE JUDGMENT RESULT OF THE PANEL ARE NOT ACCOMPANIED. WHITE COLONIES ON CANDIDA MEDIUM (NISSUI). WHEN PURELY ISOLATED IN KETSUKAN (NISUI) AND MEASURED WITH THE M50YEAST PANEL, IT WAS IDENTIFIED AS C. ALBICANS. THE FIRST WAS UNIDENTIFIABLE AND THE SECOND WAS C. ALBICANS. FROM THE COLONY CHARACTERISTICS, C. ALBICANS IS UNLIKELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16251365 ↗
• MalfunctionOct 21, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ YEAST ID THERE WAS AN INCREASE IN ABORTED PANELS WITH MESSAGE ¿ONE OR MORE FLUORESCENT WELLS ARE OUT OF RANGE¿. THE ID PORTION OF THE PANEL HAS BEEN COMPLETED AND THE ISOLATE SHOULD BE RETESTED. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTINUED AND INCREASING EVIDENCE OF PHOENIX YEAST PANELS ABORTED BY SPECIAL MESSAGE ¿ONE OR MORE FLUORESCENT WELLS ARE OUT OF RANGE¿ THE ID PORTION OF THE PANEL HAS BEEN COMPLETED AND THE ISOLATE SHOULD BE RETESTED. LOT 2060322 EXPIRATION DATE: 2023-03-31.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15645677 ↗
• MalfunctionOct 17, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ YEAST ID THERE WAS A MISIDENTIFICATION OF THE MICROORGANISM CANDIDA AURIS RELATED TO THE INSTRUMENT BDPHOENIX THAT WOULD HAVE IDENTIFIED THE FUNGUS AS C. PARAPSILOSIS. THE MISIDENTIFICATION WAS CONFIRMED BY GENETIC SEQUENCING. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIPTION: MISIDENTIFICATION OF THE MICROORGANISM CANDIDA AURIS, RELATED TO THE INSTRUMENT BDPHOENIX THAT WOULD HAVE IDENTIFIED THE FUNGUS AS C. PARAPSILOSIS. THE MISIDENTIFICATION WAS CONFIRMED BY GENETIC SEQUENCING AT THE LABORATÓRIO ESPECIAL DE MICOLOGIA DA LEMI/UNIFESP/SP, WHICH IS THE REFERENCE FOR SEQUENCING CANDIDA AURIS SAMPLES/ISOLATES FROM BRAZILIAN OUTBREAKS. THE STATE OF PERNAMBUCO HAS BEEN FACING A CANDIDA AURIS OUTBREAK SINCE JANUARY 2022. CANDIDA AURIS IS AN EMERGING FUNGUS THAT POSES A SERIOUS THREAT TO GLOBAL HEALTH BECAUSE IT CAN CAUSE INVASIVE INFECTIONS, WHICH ARE ASSOCIATED WITH HIGH MORTALITY, CAN BE MULTIRESISTANT, AND CAN LEAD TO OUTBREAKS IN HEALTHCARE FACILITIES. THE POTENTIAL MISIDENTIFICATION OF C. AURIS CASES (GENERATING FALSE NEGATIVE RESULTS AS C.PARAPSILOSIS) IS OF GREAT CONCERN, AS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15613265 ↗
• MalfunctionAug 15, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE TESTING WITH BD PHOENIX¿ YEAST ID THERE WAS A DIFFERENT YEAST ID RESULT BETWEEN PHOENIX 100 AND PHOENIX M50. CONFIRMATORY TESTING WAS PERFORMED USING MALDI-TOF, THE FINAL ID IS C. GLABRATA.THERE WAS NO INDICATION THAT RESULTS WERE REPORTED TO CLINICIANS, AND THERE WAS NO REPORT OF PATIENT IMPACT.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER USE YEAST ID PANEL FOR YEAST IDENTIFICATION. THE PANEL RESULT FROM PHOENIX 100 IS C. GLABRA, AND THE RESULT FROM PHOENIX M50 IS C. FIRMETARIA."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15229842 ↗
• MalfunctionAug 15, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ YEAST ID THE CUSTOMER RECEIVED DISCREPANT RESULTS BETWEEN TWO INSTRUMENTS. CONFIRMATORY TESTS DETERMINED THAT MISIDENTIFICATION HAD OCCURRED. THIS EVENT OCCURRED 1 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER USE YEAST ID PANEL FOR YEAST IDENTIFICATION. THE PANEL RESULT FROM PHOENIX 100 IS C. KRUSEI, AND THE RESULT FROM PHOENIX M50 IS P. WICKERHAMII. THE CUSTOMER RECHECKED THE RESULT WITH MALDI-TOF, THE FINAL ID IS C. KRUSEI."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15229489 ↗
• MalfunctionMar 8, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BD PHOENIX¿ YEAST ID MISIDENTIFIED THE ORGANISM AS CANDIDA TROPICALIS INSTEAD OF CANDIDA AURIS. THIS OCCURRED 25 SEPARATE TIMES DURING USE. CONFIRMATORY TESTING WAS DONE ON ANOTHER INSTRUMENT, WHICH IDENTIFIED THE CORRECT ORGANISM. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED TO CLINICIANS, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "YID PANELS ARE GIVEN WRONG IDENTIFICATION LIKE CANDIDA TROPICALIS INSTEAD OF CANDIDA AURIS BUT ON DIFFERENT INSTRUMENT IT HAS IDENTIFIED CORRECT ORGANSIM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13699122 ↗