Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 LARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04560189282926), received between Oct 16, 2024 and Sep 17, 2026 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812716 ↗
• MalfunctionAug 27, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED INCORRECTLY REPORTED PATIENT RESULTS FOR HBA1C ON THE HLC-723 G8 ANALYZER. THE CUSTOMER STATED THE PATIENT'S PHYSICIAN QUESTIONED THE UNEXPECTED HIGH PATIENT RESULTS. THE CUSTOMER STATED THEY REVIEWED CHROMATOGRAMS AND FOUND SEVERAL SAMPLES WITH HBE FLAGS AS WELL AS LOW RETENTION TIME. THE CUSTOMER STATED THEY ADJUSTED THE FLOW FACTOR TO RAISE THE RETENTION TIME TO AN ACCEPTABLE NUMBER, THEN RERAN ALL SAMPLES THAT ORIGINALLY PRODUCED A RESULT WITH A HBE FLAG RESULT. THE CUSTOMER CLARIFIED THAT THE LAB TECHNICIAN RUNNING SAMPLES FOR THE DAY DID NOT REALIZE THAT THE AMOUNT OF HBE FLAGS RECEIVED WAS NOT NORMAL AND FAILED TO LOOK INTO THE REASON FOR THE NUMEROUS HBE FLAGS PRIOR TO REPORTING OUT THE RESULTS. THE CUSTOMER DID NOT PROVIDE TOSOH TECHNICAL SUPPORT SPECIALIST (TSS) WITH ANY OF THE REPORTED PATIENT RESULTS, NOR WERE ANY PATIENT TREATMENT AFFECTED. THE CUSTOMER STATED THEY ONLY REPORTED THE ISSUE FOR DOCUMENTATION PURPOSES AND DID NOT REQUIRE ANY FURTHER ACTION FROM TSS. TECHNICAL SUPPORT SPECIALIST (TSS) DETERMINED THE CAUSE OF THE REPORTED EVENT WAS TRACED TO USER ERROR. THE G8 ANALYZER IS FUNCTIONING AS EXPECTED. THERE WAS NO INDICATION OF ANY PATIENT IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903516 ↗
• MalfunctionOct 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED FAILURE OF COLLEGE OF AMERICAN PATHOLOGISTS (CAP) GH-06 SURVEY ON THE G8 ANALYZER. THE SAMPLE RESULT WAS 8.3% AND THE ACCEPTABLE RANGE IS 7.2%-8.2%. THE CUSTOMER VERIFIED THAT QUALITY CONTROL (QC) PASSED AT THE TIME OF TESTING. A TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO RUN CALIBRATORS AS SAMPLES, WHERE CALIBRATOR 1 RESULTS ARE NOT MATCHING THE BOTTLE VALUE. THE CALIBRATOR 1 BOTTLE VALUE WAS 5.9% AND THE VALUE RESULTS WERE 4.1% WITH LOW TOTAL AREA. THERE WAS NO PROBLEM WITH CALIBRATOR 2 VALUES AND QC WAS WITHIN RANGE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO FURTHER INVESTIGATE THE REPORTED EVENT. 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 20467498 ↗