Tosoh Automated Glycohemoglobin Analyzer HLC-723G8RRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00853931008009), received between Oct 20, 2022 and Apr 3, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Device Ingredient or Reagent Problem

  A CUSTOMER REPORTED INCONSISTENT RESULTS FOR ONE HBA1C SAMPLE ON THE HLC-723 G8 ANALYZER. QUALITY CONTROL (QC) WAS CONFIRMED TO BE IN RANGE AND THERE ARE NO ISSUES WITH ANY OTHER SAMPLES. THE DOCTOR IS QUESTIONING THE RESULTS 7.8% COMPARED TO 7.2% RECEIVED BY QUEST DIAGNOSTICS. QUEST DIAGNOSTICS USES TURBIDIMETRIC INHIBITION IMMUNOASSAY TO TEST FOR HBA1C COMPARED TO HIGH PRESSURE LIQUID CHROMATOGRAPHY (HPLC) TESTING USED BY TOSOH. THERE WAS NO PATIENT HARM OR TREATMENT CHANGE DUE TO THE POTENTIAL DISCREPANT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779433 ↗
• MalfunctionMay 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED A POTENTIAL DISCREPANT PATIENT RESULT WITH ERRATIC TOTAL AREAS ON THE FIRST SAMPLE RACK POSITION ON THE HLC-723 G8 ANALYZER. THE CUSTOMER STATED THE TOTAL AREA CAN VARY ANYWHERE FROM 9 TO 18,000 (ACCEPTABLE RANGE 500-4000) BUT ONLY OCCURS ON THE FIRST SAMPLE POSITION IN THE RACK. THE CUSTOMER ALSO STATED THE RESULTS WOULD "DASH OUT" IN THE FIRST SAMPLE RACK POSITION. THE CUSTOMER REMOVED THE DISCREPANT RESULT SAMPLE OUT OF THE FIRST SAMPLE RACK POSITION AND INTO AN ALTERNATIVE SAMPLING POSITION, THEN RERAN SAMPLE. THE RESULTS WERE WITHIN ACCEPTABLE RANGE. THE CUSTOMER REQUESTED FIELD SERVICE TO IDENTIFY THE NEED TO USE THE FIRST SAMPLE RACK POSITION FOR A PRIMING SAMPLE AND NOT PATIENT SAMPLES. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21997955 ↗
• MalfunctionMar 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED FAILING GH2-B 2024 COLLEGE OF AMERICAN PATHOLOGISTS (CAP) SURVEY IN NOVEMBER 2024 FOR HEMOGLOBIN A1C ON THE HLC-723 G8 ANALYZER. THE CUSTOMER FAILED SAMPLES GH-11 AND GH-12 BUT PASSED GH-13. THE CUSTOMER STATED THEIR QUALITY CONTROLS(QC) WERE WITHIN ACCEPTABLE RANGE, HOWEVER AT THE TIME OF THE SURVEY RUN, QC WAS RUNNING ON THE HIGH END OF RANGE. THE CUSTOMER CHANGED THE COLUMN AND CALIBRATED AGAIN RESULTING IN SHIFT WITH QC BACK TO ACCEPTABLE RANGE FOR ALL LEVELS. THE CUSTOMER THEN RERAN THE CAP SURVEY IN DECEMBER 2024 AND PASSED; RESULTS FOR THE DECEMBER TESTING WERE NOT PROVIDED. TOSOH QUALITY LAB DID NOT PARTICIPATE IN THE NOVEMBER 2024 CAP SURVEY BUT PASSED ALL FIVE PROFICIENCY SAMPLES FOR HEMOGLOBIN A1C IN DECEMBER 2024 SURVEY. THE CUSTOMER DID NOT REPORT THE FAILED SURVEY AT TIME OF EVENT, BUT RECENTLY SENT DATA TO TOSOH TECHNICAL SUPPORT FOR FURTHER REVIEW. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21590196 ↗
• MalfunctionNov 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED FLUCTUATING SAMPLE RESULTS ON THE G8 ANALYZER. THE RESULTS WERE REPORTED OUT TO THE PATIENT'S DOCTOR WHO QUESTIONED THEM BECAUSE SEVERAL OF THE SAMPLE RESULTS WERE HIGHER THAN EXPECTED. NO TREATMENT WAS CHANGED BASED ON THE FLUCTUATING RESULTS. THE RETENTION TIME WAS AT 0.57 MINUTES, ACCEPTABLE RANGE IS 0.56-0.62 MINUTES. SINCE THE RETENTION TIME WAS ON THE LOWER END OF THE ACCEPTABLE RANGE, THE CUSTOMER CHANGED THE FLOW FACTOR FROM 1.09 TO 1.06. AFTER THE ADJUSTMENT, THE CUSTOMER RERAN THE SAMPLES AND THEY MATCHED THE EXPECTED RESULTS. THE CUSTOMER CALIBRATED AND THE G8 ANALYZER IS FUNCTIONING AS EXPECTED. NO FURTHER ACTION IS REQUIRED. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641885 ↗
• MalfunctionMar 21, 2024Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  A TOSOH CLINICAL SUPPORT SPECIALIST (CSS) REPORTED A COMPLAINT OF 710 Z-1AXIS ERROR AND Z1:2.12, FXAB, LOVR ERROR CODE 999 (LIMIT WAS DETECTED; MOVED TOO FAR IN THE LIMIT DIRECTION) LOGGED SEVERAL TIMES ON THE ERROR LOG. THE CSS NOTED THESE ERRORS WERE LOGGED INTERMITTENTLY, HOWEVER 710 Z-AXIS ERROR WAS REPRODUCIBLE ONSITE MULTIPLE TIMES. THE LAB DIRECTOR ALSO NOTED THERE MAY HAVE BEEN THREE (3) FALSELY ELEVATED SAMPLES PRIOR TO CSS ARRIVAL. THE CUSTOMER CONFIRMED THESE RESULTS WERE REPORTED OUT, HOWEVER, THERE WAS NO CONFIRMATION BY THE CUSTOMER OF ANY PATIENT IMPACT DUE TO THE DISCREPANT PATIENT RESULTS. THE CSS ASKED THE LAB DIRECTOR TO PULL THE SAMPLES AND SAVE THEM FOR FIELD SERVICE ENGINEER (FSE). A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO FURTHER INVESTIGATE AND ADDRESS THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18952175 ↗
• MalfunctionOct 20, 2022No Audible Alarm; Smoking; No Audible Alarm; Smoking

  WHILE THE TOSOH FIELD SERVICE ENGINEER (FSE) WAS AT THE CUSTOMER¿S SITE PERFORMING A PERIODIC MAINTENANCE (PM) ON THE G8 ANALYZER, THE ANALYZER MADE AN AUDIBLE POPPING AND SIZZLING SOUND DURING A DRAIN FLUSH. THE SORTER NO LONGER RECOGNIZES THE SENSOR AND WISPS OF SMOKE WAS OBSERVED FROM THE FRONT OF THE ANALYZER. NO FLAMES OBSERVED AND NO INJURIES TO THE USERS OR THE FIELD SERVICE ENGINEER (FSE) WAS REPORTED. THE ANALYZER IS DOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15639470 ↗