ID 32 C 32200Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03573026066383), received between Aug 30, 2019 and Feb 9, 2022 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (13 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2022Nonstandard Device; Nonstandard Device

  INTENDED USE: ID 32 C IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF YEASTS. IT USES MINIATURIZED TESTS AS WELL AS A SPECIALLY 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 (B)(6) REPORTED TO BIOMÉRIEUX POTENTIAL DELAYED RESULTS IN ASSOCIATION WITH THE PRODUCT ID 32 C 25STRIPS+25MEDIA (REF 32200, BATCH NUMBER 1008781060, EXPIRY DATE 11-JUN-2022). THE CUSTOMER STATED THEY OBSERVED FIVE (5) STRIPS WITH VISUAL DEFECT. IT WAS REPORTED THAT THE CUSTOMER CLAIMED A DELAYED RESULT; THE CUSTOMER COULD NOT USE THE PRODUCT DUE TO A VISUAL DEFECT OBSERVED BEFORE USE, AND THAT FIVE STRIPS WERE IMPACTED IN A KIT OF TWENTY FIVE STRIPS. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. AN INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13497487 ↗
• MalfunctionDec 22, 2021Nonstandard Device; Nonstandard Device

  INTENDED USE: ID 32 C IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF YEASTS. IT USES MINIATURIZED TESTS AS WELL AS A SPECIALLY 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: BIOMÉRIEUX INITIATED AN INTERNAL COMPLAINT FOR STRIPS THERMOFORMING DEFECT IDENTIFIED BY AN INDUSTRIALIZATION TECHNICIAN IN (B)(4) MANUFACTURING SITE ((B)(4)): THERMOFORMING OF NON-COMPLIANT CUPS IN ASSOCIATION WITH THE PRODUCT ID 32 C 25STRIPS+25MEDIA (REF. 32200, LOT 1008781060, EXPIRATION DATE 11-JUN-2022). DURING AN INDUSTRIALIZATION CHECK ON ADDITIONAL STRAINS, A REFERENCE GALLERY (BATCH ALREADY RELEASED) IS USED IN PARALLEL WITH THE TEST. WHEN PREPARING FOR AN INDUSTRIALIZATION TEST, TECHNICIANS ALERT FOR THE DEFECT OBSERVED. ACCORDING TO THE INTERNAL INVESTIGATION, THIS DEFECT COULD LEAD TO THE FOLLOWING SITUATIONS: NO RESULT OR DELAYED RESULT. INCORRECT ID RESULT (FALSE RESULT) ¿ WORST CASE IDENTIFIED. THERE IS NO INDICATION OR REPORT THAT THIS EVENT HAS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13069113 ↗
• MalfunctionJan 13, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A SCIENTIFIC PUBLICATION ENTITLED, "HIGH RATES OF MISIDENTIFICATION OF UNCOMMON CANDIDA SPECIES CAUSING BLOODSTREAM INFECTIONS USING CONVENTIONAL PHENOTYPIC METHODS" BY HUANG Y. ET. AL. THIS PUBLICATION NOTED MULTIPLE MISIDENTIFICATIONS IN ASSOCIATION WITH API® ID 32 C (REF 32200, BATCH # UNKNOWN) WHEN TESTING UNCOMMON CANDIDA SPECIES (SPECIES OTHER THAN C. ALBICANS, C. PARAPSILOSIS, C. GLABRATA,C. TROPICALIS, AND C. KRUSEI). THE AUTHORS TESTED 51 CANDIDA ISOLATES USING ID 32 C REF 32200 AND FOR 18 ISOLATES THEY HAD OBTAINED INCORRECT IDENTIFICATION RESULTS. OF THOSE 18 STRAINS, 7 SPECIES WERE NOT INCLUDED IN THE ID32C KNOWLEDGE BASE (KB). ONE (1) C. INFANTICOLA OR C. SORBOPHILA MISIDENTIFIED AS C. CATENULATE (OUT OF KB). ONE (1) C. ALBICANS MISIDENTIFIED AS C. FAMATA. TWO (2) C. GUILLIERMONDII MISIDENTIFIED AS C. FAMATA. ONE (1) C. PALMIOLEOPHILA MISIDENTIFIED AS C. FAMATA (OUT OF KB). ONE (1) C. TROPICALIS MISIDENTIFIED AS C. INTERMEDIA. ONE (1) C. DUOBUSHAEMULONII OR C. HAEMULONII MISIDENTIFIED AS C. LUSITANIAE (OUT OF KB). ONE (1) C. HAEMULONII MISIDENTIFIED AS C. SAKE (OUT OF KB). THREE (3) C. PARAPSILOSIS WERE MISIDENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11166899 ↗
• MalfunctionOct 17, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2019 SCIENTIFIC PUBLICATION ENTITLED, "IDENTIFICATION AND ANTIFUNGAL SUSCEPTIBILITY PROFILES OF KODAMAEA OHMERI BASED ON A SEVEN-YEAR MULTICENTER SURVEILLANCE STUDY" BY ZHOU M, ET AL. THE PUBLICATION NOTED TWO (2) MISIDENTIFICATIONS OF KODAMAEA OHMERI IN ASSOCIATION WITH THE API® ID 32 C. SPECIFIC LOT NUMBERS USED DURING THE STUDY WERE NOT DISCLOSED. THIS PUBLICATION COMPARES IDENTIFICATION METHODS FOR ACCURACY IN IDENTIFYING KODAMAEA OHMERI. THE 62 PATIENT STRAINS OF KODAMAEA OHMERI USED IN THIS STUDY WERE COLLECTED FROM 24 HOSPITALS IN CHINA OVER A SEVEN YEAR PERIOD. THE STRAINS WERE VERIFIED TO BE KODAMAEA OHMERI BY 26S RDNA SEQUENCING. THE ORIGINAL IDENTIFICATION METHODS USED AND RESULTS OBTAINED BY THE DIFFERENT HOSPITALS WERE COMPARED TO THE EXPECTED IDENTIFICATION. SIX (6) OF THE 62 STRAINS WERE ORIGINALLY IDENTIFIED USING THE ATB 32 C WITH TWO (2) MISIDENTIFICATIONS. FOUR (4) OF THE STRAINS WERE CORRECTLY IDENTIFIED AS KODAMAEA OHMERI. ATB 32 C MISIDENTIFICATIONS: 1 X CANDIDA GLABRATA, 1 X CANDIDA ALBICANS. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVEN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9205114 ↗
• MalfunctionOct 17, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2019 SCIENTIFIC PUBLICATION ENTITLED, "IDENTIFICATION AND ANTIFUNGAL SUSCEPTIBILITY PROFILES OF KODAMAEA OHMERI BASED ON A SEVEN-YEAR MULTICENTER SURVEILLANCE STUDY" BY ZHOU M, ET AL. THE PUBLICATION NOTED TWO (2) MISIDENTIFICATIONS OF KODAMAEA OHMERI IN ASSOCIATION WITH THE API® ID 32 C. SPECIFIC LOT NUMBERS USED DURING THE STUDY WERE NOT DISCLOSED. THIS PUBLICATION COMPARES IDENTIFICATION METHODS FOR ACCURACY IN IDENTIFYING KODAMAEA OHMERI. THE 62 PATIENT STRAINS OF KODAMAEA OHMERI USED IN THIS STUDY WERE COLLECTED FROM 24 HOSPITALS IN CHINA OVER A SEVEN YEAR PERIOD. THE STRAINS WERE VERIFIED TO BE KODAMAEA OHMERI BY 26S RDNA SEQUENCING. THE ORIGINAL IDENTIFICATION METHODS USED AND RESULTS OBTAINED BY THE DIFFERENT HOSPITALS WERE COMPARED TO THE EXPECTED IDENTIFICATION. SIX (6) OF THE 62 STRAINS WERE ORIGINALLY IDENTIFIED USING THE ATB 32 C WITH TWO (2) MISIDENTIFICATIONS. FOUR (4) OF THE STRAINS WERE CORRECTLY IDENTIFIED AS KODAMAEA OHMERI. ATB 32 C MISIDENTIFICATIONS. 1 X CANDIDA GLABRATA. 1 X CANDIDA ALBICANS. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVEN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9205113 ↗
• MalfunctionAug 30, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A SCIENTIFIC PUBLICATION ENTITLED, "CYBERLINDNERA FABIANII FUGEMIA OUTBREAK IN PRETERM NEONATES IN KUWAIT AND LITERATURE REVIEW" BY AL-SWEIH N, ET AL. THE PUBLICATION NOTED THE MISIDENTIFICATION OF CYBERLINDNERA FABIANII AS CANDIDA UTILIS IN ASSOCIATION WITH THE API® ID 32 C (REF 32200). THE PUBLICATION DOES NOT REFERENCE THE LOT NUMBER(S) OF API® ID 32 C USED. THE ISOLATES WERE IDENTIFIED AS CYBERLINDNERA FABIANII VIA POLYMERASE CHAIN REACTION (PCR) TESTING. THE PUBLICATION DISCUSSES THE TREATMENTS OF 10 PRETERM NEONATE PATIENTS, TWO (2) OF WHICH DIED. PATIENT 2 DIED BEFORE ANTIFUNGAL TREATMENT HAD BEGUN AND PATIENT 10 DIED AFTER RECEIVING 10 DAYS OF ANTIFUNGAL TREATMENT (AMPHOTERICIN B). ANTIFUNGAL SUSCEPTIBILITY TESTING WAS COMPLETED USING ETEST®. SURVIVING PATIENTS RECEIVED TREATMENTS WITH ONE OR MORE OF THE FOLLOWING ANTIFUNGALS: AMPHOTERICIN B, FLUCONAZOLE, CASPOFUNGIN. ALL PATIENTS WERE BETWEEN 24 - 29 WEEKS IN GESTATION AGE. ALL RECEIVED PRIOR TREATMENT OF AMPICILLIN AND AMIKACIN. CYBERLINDNERA FABIANII IS NOT A CLAIMED SPECIES IN THE DATABASE FOR THE API® ID 32 C. REGARDING ORGANISMS NOT CLAIMED IN THE DATABASE, THE INSTRUCTION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8950232 ↗
• MalfunctionAug 30, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A SCIENTIFIC PUBLICATION ENTITLED, "CYBERLINDNERA FABIANII FUGEMIA OUTBREAK IN PRETERM NEONATES IN KUWAIT AND LITERATURE REVIEW" BY AL-SWEIH N, ET AL. THE PUBLICATION NOTED THE MISIDENTIFICATION OF CYBERLINDNERA FABIANII AS CANDIDA UTILIS IN ASSOCIATION WITH THE API® ID 32 C (REF 32200). THE PUBLICATION DOES NOT REFERENCE THE LOT NUMBER(S) OF API® ID 32 C USED. THE ISOLATES WERE IDENTIFIED AS CYBERLINDNERA FABIANII VIA POLYMERASE CHAIN REACTION (PCR) TESTING. THE PUBLICATION DISCUSSES THE TREATMENTS OF 10 PRETERM NEONATE PATIENTS, TWO (2) OF WHICH DIED. PATIENT 2 DIED BEFORE ANTIFUNGAL TREATMENT HAD BEGUN AND PATIENT 10 DIED AFTER RECEIVING 10 DAYS OF ANTIFUNGAL TREATMENT (AMPHOTERICIN B). ANTIFUNGAL SUSCEPTIBILITY TESTING WAS COMPLETED USING ETEST®. SURVIVING PATIENTS RECEIVED TREATMENTS WITH ONE OR MORE OF THE FOLLOWING ANTIFUNGALS: AMPHOTERICIN B, FLUCONAZOLE, CASPOFUNGIN. ALL PATIENTS WERE BETWEEN 24 - 29 WEEKS IN GESTATION AGE. ALL RECEIVED PRIOR TREATMENT OF AMPICILLIN AND AMIKACIN. CYBERLINDNERA FABIANII IS NOT A CLAIMED SPECIES IN THE DATABASE FOR THE API® ID 32 C. REGARDING ORGANISMS NOT CLAIMED IN THE DATABASE, THE INSTRUCTION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8950230 ↗
• MalfunctionAug 30, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A SCIENTIFIC PUBLICATION ENTITLED, "CYBERLINDNERA FABIANII FUGEMIA OUTBREAK IN PRETERM NEONATES IN KUWAIT AND LITERATURE REVIEW" BY AL-SWEIH N, ET AL. THE PUBLICATION NOTED THE MISIDENTIFICATION OF CYBERLINDNERA FABIANII AS CANDIDA UTILIS IN ASSOCIATION WITH THE API® ID 32 C (REF 32200). THE PUBLICATION DOES NOT REFERENCE THE LOT NUMBER(S) OF API® ID 32 C USED. THE ISOLATES WERE IDENTIFIED AS CYBERLINDNERA FABIANII VIA POLYMERASE CHAIN REACTION (PCR) TESTING. THE PUBLICATION DISCUSSES THE TREATMENTS OF 10 PRETERM NEONATE PATIENTS, TWO (2) OF WHICH DIED. PATIENT 2 DIED BEFORE ANTIFUNGAL TREATMENT HAD BEGUN AND PATIENT 10 DIED AFTER RECEIVING 10 DAYS OF ANTIFUNGAL TREATMENT (AMPHOTERICIN B). ANTIFUNGAL SUSCEPTIBILITY TESTING WAS COMPLETED USING ETEST®. SURVIVING PATIENTS RECEIVED TREATMENTS WITH ONE OR MORE OF THE FOLLOWING ANTIFUNGALS: AMPHOTERICIN B, FLUCONAZOLE, CASPOFUNGIN. ALL PATIENTS WERE BETWEEN 24 - 29 WEEKS IN GESTATION AGE. ALL RECEIVED PRIOR TREATMENT OF AMPICILLIN AND AMIKACIN. CYBERLINDNERA FABIANII IS NOT A CLAIMED SPECIES IN THE DATABASE FOR THE API® ID 32 C. REGARDING ORGANISMS NOT CLAIMED IN THE DATABASE, THE INSTRUCTION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8950229 ↗
• MalfunctionAug 30, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A SCIENTIFIC PUBLICATION ENTITLED, "CYBERLINDNERA FABIANII FUGEMIA OUTBREAK IN PRETERM NEONATES IN KUWAIT AND LITERATURE REVIEW" BY AL-SWEIH N, ET AL. THE PUBLICATION NOTED THE MISIDENTIFICATION OF CYBERLINDNERA FABIANII AS CANDIDA UTILIS IN ASSOCIATION WITH THE API® ID 32 C (REF 32200). THE PUBLICATION DOES NOT REFERENCE THE LOT NUMBER(S) OF API® ID 32 C USED. THE ISOLATES WERE IDENTIFIED AS CYBERLINDNERA FABIANII VIA POLYMERASE CHAIN REACTION (PCR) TESTING. THE PUBLICATION DISCUSSES THE TREATMENTS OF 10 PRETERM NEONATE PATIENTS, TWO (2) OF WHICH DIED. PATIENT 2 DIED BEFORE ANTIFUNGAL TREATMENT HAD BEGUN AND PATIENT 10 DIED AFTER RECEIVING 10 DAYS OF ANTIFUNGAL TREATMENT (AMPHOTERICIN B). ANTIFUNGAL SUSCEPTIBILITY TESTING WAS COMPLETED USING ETEST®. SURVIVING PATIENTS RECEIVED TREATMENTS WITH ONE OR MORE OF THE FOLLOWING ANTIFUNGALS: AMPHOTERICIN B, FLUCONAZOLE, CASPOFUNGIN. ALL PATIENTS WERE BETWEEN 24 - 29 WEEKS IN GESTATION AGE. ALL RECEIVED PRIOR TREATMENT OF AMPICILLIN AND AMIKACIN. CYBERLINDNERA FABIANII IS NOT A CLAIMED SPECIES IN THE DATABASE FOR THE API® ID 32 C. REGARDING ORGANISMS NOT CLAIMED IN THE DATABASE, THE INSTRUCTION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8950228 ↗
• MalfunctionAug 30, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A SCIENTIFIC PUBLICATION ENTITLED, "CYBERLINDNERA FABIANII FUGEMIA OUTBREAK IN PRETERM NEONATES IN KUWAIT AND LITERATURE REVIEW" BY AL-SWEIH N, ET AL. THE PUBLICATION NOTED THE MISIDENTIFICATION OF CYBERLINDNERA FABIANII AS CANDIDA UTILIS IN ASSOCIATION WITH THE API® ID 32 C (REF 32200). THE PUBLICATION DOES NOT REFERENCE THE LOT NUMBER(S) OF API® ID 32 C USED. THE ISOLATES WERE IDENTIFIED AS CYBERLINDNERA FABIANII VIA POLYMERASE CHAIN REACTION (PCR) TESTING. THE PUBLICATION DISCUSSES THE TREATMENTS OF 10 PRETERM NEONATE PATIENTS, TWO (2) OF WHICH DIED. PATIENT 2 DIED BEFORE ANTIFUNGAL TREATMENT HAD BEGUN AND PATIENT 10 DIED AFTER RECEIVING 10 DAYS OF ANTIFUNGAL TREATMENT (AMPHOTERICIN B). ANTIFUNGAL SUSCEPTIBILITY TESTING WAS COMPLETED USING ETEST®. SURVIVING PATIENTS RECEIVED TREATMENTS WITH ONE OR MORE OF THE FOLLOWING ANTIFUNGALS: AMPHOTERICIN B, FLUCONAZOLE, CASPOFUNGIN. ALL PATIENTS WERE BETWEEN 24 - 29 WEEKS IN GESTATION AGE. ALL RECEIVED PRIOR TREATMENT OF AMPICILLIN AND AMIKACIN. CYBERLINDNERA FABIANII IS NOT A CLAIMED SPECIES IN THE DATABASE FOR THE API® ID 32 C. REGARDING ORGANISMS NOT CLAIMED IN THE DATABASE, THE INSTRUCTION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8950227 ↗
• MalfunctionAug 30, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A SCIENTIFIC PUBLICATION ENTITLED, "CYBERLINDNERA FABIANII FUGEMIA OUTBREAK IN PRETERM NEONATES IN KUWAIT AND LITERATURE REVIEW" BY AL-SWEIH N, ET AL. THE PUBLICATION NOTED THE MISIDENTIFICATION OF CYBERLINDNERA FABIANII AS CANDIDA UTILIS IN ASSOCIATION WITH THE API® ID 32 C (REF 32200). THE PUBLICATION DOES NOT REFERENCE THE LOT NUMBER(S) OF API® ID 32 C USED. THE ISOLATES WERE IDENTIFIED AS CYBERLINDNERA FABIANII VIA POLYMERASE CHAIN REACTION (PCR) TESTING. THE PUBLICATION DISCUSSES THE TREATMENTS OF 10 PRETERM NEONATE PATIENTS, TWO (2) OF WHICH DIED. PATIENT 2 DIED BEFORE ANTIFUNGAL TREATMENT HAD BEGUN AND PATIENT 10 DIED AFTER RECEIVING 10 DAYS OF ANTIFUNGAL TREATMENT (AMPHOTERICIN B). ANTIFUNGAL SUSCEPTIBILITY TESTING WAS COMPLETED USING ETEST®. SURVIVING PATIENTS RECEIVED TREATMENTS WITH ONE OR MORE OF THE FOLLOWING ANTIFUNGALS: AMPHOTERICIN B, FLUCONAZOLE, CASPOFUNGIN. ALL PATIENTS WERE BETWEEN 24 - 29 WEEKS IN GESTATION AGE. ALL RECEIVED PRIOR TREATMENT OF AMPICILLIN AND AMIKACIN. CYBERLINDNERA FABIANII IS NOT A CLAIMED SPECIES IN THE DATABASE FOR THE API® ID 32 C. REGARDING ORGANISMS NOT CLAIMED IN THE DATABASE, THE INSTRUCTION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8950220 ↗
• MalfunctionAug 30, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A SCIENTIFIC PUBLICATION ENTITLED, "CYBERLINDNERA FABIANII FUGEMIA OUTBREAK IN PRETERM NEONATES IN KUWAIT AND LITERATURE REVIEW" BY AL-SWEIH N, ET AL. THE PUBLICATION NOTED THE MISIDENTIFICATION OF CYBERLINDNERA FABIANII AS CANDIDA UTILIS IN ASSOCIATION WITH THE API® ID 32 C (REF 32200). THE PUBLICATION DOES NOT REFERENCE THE LOT NUMBER(S) OF API® ID 32 C USED. THE ISOLATES WERE IDENTIFIED AS CYBERLINDNERA FABIANII VIA POLYMERASE CHAIN REACTION (PCR) TESTING. THE PUBLICATION DISCUSSES THE TREATMENTS OF 10 PRETERM NEONATE PATIENTS, TWO (2) OF WHICH DIED. PATIENT 2 DIED BEFORE ANTIFUNGAL TREATMENT HAD BEGUN AND PATIENT 10 DIED AFTER RECEIVING 10 DAYS OF ANTIFUNGAL TREATMENT (AMPHOTERICIN B). ANTIFUNGAL SUSCEPTIBILITY TESTING WAS COMPLETED USING ETEST®. SURVIVING PATIENTS RECEIVED TREATMENTS WITH ONE OR MORE OF THE FOLLOWING ANTIFUNGALS: AMPHOTERICIN B, FLUCONAZOLE, CASPOFUNGIN. ALL PATIENTS WERE BETWEEN 24 - 29 WEEKS IN GESTATION AGE. ALL RECEIVED PRIOR TREATMENT OF AMPICILLIN AND AMIKACIN. CYBERLINDNERA FABIANII IS NOT A CLAIMED SPECIES IN THE DATABASE FOR THE API® ID 32 C. REGARDING ORGANISMS NOT CLAIMED IN THE DATABASE, THE INSTRUCTION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8950217 ↗
• MalfunctionAug 30, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A SCIENTIFIC PUBLICATION ENTITLED, "CYBERLINDNERA FABIANII FUGEMIA OUTBREAK IN PRETERM NEONATES IN KUWAIT AND LITERATURE REVIEW" BY AL-SWEIH N, ET AL. THE PUBLICATION NOTED THE MISIDENTIFICATION OF CYBERLINDNERA FABIANII AS CANDIDA UTILIS IN ASSOCIATION WITH THE API® ID 32 C (REF 32200). THE PUBLICATION DOES NOT REFERENCE THE LOT NUMBER(S) OF API® ID 32 C USED. THE ISOLATES WERE IDENTIFIED AS CYBERLINDNERA FABIANII VIA POLYMERASE CHAIN REACTION (PCR) TESTING. THE PUBLICATION DISCUSSES THE TREATMENTS OF 10 PRETERM NEONATE PATIENTS, TWO (2) OF WHICH DIED. PATIENT 2 DIED BEFORE ANTIFUNGAL TREATMENT HAD BEGUN AND PATIENT 10 DIED AFTER RECEIVING 10 DAYS OF ANTIFUNGAL TREATMENT (AMPHOTERICIN B). ANTIFUNGAL SUSCEPTIBILITY TESTING WAS COMPLETED USING ETEST®. SURVIVING PATIENTS RECEIVED TREATMENTS WITH ONE OR MORE OF THE FOLLOWING ANTIFUNGALS: AMPHOTERICIN B, FLUCONAZOLE, CASPOFUNGIN. ALL PATIENTS WERE BETWEEN 24 - 29 WEEKS IN GESTATION AGE. ALL RECEIVED PRIOR TREATMENT OF AMPICILLIN AND AMIKACIN. CYBERLINDNERA FABIANII IS NOT A CLAIMED SPECIES IN THE DATABASE FOR THE API® ID 32 C. REGARDING ORGANISMS NOT CLAIMED IN THE DATABASE, THE INSTRUCTION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8950215 ↗
• MalfunctionAug 30, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A SCIENTIFIC PUBLICATION ENTITLED, "CYBERLINDNERA FABIANII FUGEMIA OUTBREAK IN PRETERM NEONATES IN KUWAIT AND LITERATURE REVIEW" BY AL-SWEIH N, ET AL. THE PUBLICATION NOTED THE MISIDENTIFICATION OF CYBERLINDNERA FABIANII AS CANDIDA UTILIS IN ASSOCIATION WITH THE API® ID 32 C (REF 32200). THE PUBLICATION DOES NOT REFERENCE THE LOT NUMBER(S) OF API® ID 32 C USED. THE ISOLATES WERE IDENTIFIED AS CYBERLINDNERA FABIANII VIA POLYMERASE CHAIN REACTION (PCR) TESTING. THE PUBLICATION DISCUSSES THE TREATMENTS OF 10 PRETERM NEONATE PATIENTS, TWO (2) OF WHICH DIED. PATIENT 2 DIED BEFORE ANTIFUNGAL TREATMENT HAD BEGUN AND PATIENT 10 DIED AFTER RECEIVING 10 DAYS OF ANTIFUNGAL TREATMENT (AMPHOTERICIN B). ANTIFUNGAL SUSCEPTIBILITY TESTING WAS COMPLETED USING ETEST®. SURVIVING PATIENTS RECEIVED TREATMENTS WITH ONE OR MORE OF THE FOLLOWING ANTIFUNGALS: AMPHOTERICIN B, FLUCONAZOLE, CASPOFUNGIN. ALL PATIENTS WERE BETWEEN 24 - 29 WEEKS IN GESTATION AGE. ALL RECEIVED PRIOR TREATMENT OF AMPICILLIN AND AMIKACIN. CYBERLINDNERA FABIANII IS NOT A CLAIMED SPECIES IN THE DATABASE FOR THE API® ID 32 C. REGARDING ORGANISMS NOT CLAIMED IN THE DATABASE, THE INSTRUCTION

  Patient problems: Death; No Consequences Or Impact To Patient

  MAUDE report 8950214 ↗
• MalfunctionAug 30, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A SCIENTIFIC PUBLICATION ENTITLED, "CYBERLINDNERA FABIANII FUGEMIA OUTBREAK IN PRETERM NEONATES IN KUWAIT AND LITERATURE REVIEW" BY AL-SWEIH N, ET AL. THE PUBLICATION NOTED THE MISIDENTIFICATION OF CYBERLINDNERA FABIANII AS CANDIDA UTILIS IN ASSOCIATION WITH THE API® ID 32 C (REF 32200). THE PUBLICATION DOES NOT REFERENCE THE LOT NUMBER(S) OF API® ID 32 C USED. THE ISOLATES WERE IDENTIFIED AS CYBERLINDNERA FABIANII VIA POLYMERASE CHAIN REACTION (PCR) TESTING. THE PUBLICATION DISCUSSES THE TREATMENTS OF 10 PRETERM NEONATE PATIENTS, TWO (2) OF WHICH DIED. PATIENT 2 DIED BEFORE ANTIFUNGAL TREATMENT HAD BEGUN AND PATIENT 10 DIED AFTER RECEIVING 10 DAYS OF ANTIFUNGAL TREATMENT (AMPHOTERICIN B). ANTIFUNGAL SUSCEPTIBILITY TESTING WAS COMPLETED USING ETEST®. SURVIVING PATIENTS RECEIVED TREATMENTS WITH ONE OR MORE OF THE FOLLOWING ANTIFUNGALS: AMPHOTERICIN B, FLUCONAZOLE, CASPOFUNGIN. ALL PATIENTS WERE BETWEEN 24 - 29 WEEKS IN GESTATION AGE. ALL RECEIVED PRIOR TREATMENT OF AMPICILLIN AND AMIKACIN. CYBERLINDNERA FABIANII IS NOT A CLAIMED SPECIES IN THE DATABASE FOR THE API® ID 32 C. REGARDING ORGANISMS NOT CLAIMED IN THE DATABASE, THE INSTRUCTION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8950213 ↗