Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01Recalls & reported problems
Tosoh Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04562185404920), received between Sep 25, 2026 and Sep 25, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892535 ↗
Other Assay, Glycosylated Hemoglobin devices
- Atellica CH A1c_E 11097536Siemens Healthcare Diagnostics Inc. · ASSAY, GLYCOSYLATED HEMOGLOBIN3 recalls25 reports
- Atellica CH Fruc 11097637Siemens Healthcare Diagnostics Inc. · ASSAY, GLYCOSYLATED HEMOGLOBIN2 recalls0 reports
- Tosoh Automated Glycohemoglobin Analyzer HLC-723G8Tosoh Corporation · Assay, Glycosylated Hemoglobin71 reports
- A1CNow®+ Multi-UseTest System (20 count) 3021Polymer Technology Systems, Inc. · ASSAY, GLYCOSYLATED HEMOGLOBIN1 recall11 reports
- ADVIA® Chemistry FRUC Reagents 10361941Siemens Healthcare Diagnostics Inc. · ASSAY, GLYCOSYLATED HEMOGLOBIN1 recall0 reports
- DCA™ Systems Hemoglobin A1c Reagent Kit 10311134Siemens Healthcare Diagnostics Inc. · ASSAY, GLYCOSYLATED HEMOGLOBIN1 recall0 reports
- Tinaquant Hemoglobin A1c III 5336163190Roche Diagnostics GmbH · ASSAY, GLYCOSYLATED HEMOGLOBIN45 reports
- Tina-quant Hemoglobin A1cDx Gen.3 08445699190Roche Diagnostics GmbH · ASSAY, GLYCOSYLATED HEMOGLOBIN11 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page