Tosoh recalls HLC-723G8-ST and HLC-723G8-LA analyzers with software version 5.23. HbAE can cause invalid diabetes test results if Flag 43 isn't enabled. Users should check software settings to avoid inaccurate readings.
HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Customers should exercise caution when reviewing chromatograms and ensure that Flag 43 is enabled on their device to avoid reporting invalid test results in the presence of HbAE.
Take action
Contact the company
📍Recalling firmTosoh Bioscience Inc3600 Gantz Rd · Grove City, OH 43123-1895
“Tosoh HPLC Analyzer HbAE Interference Risk: Review Chromatograms Carefully.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70898-tosoh-hplc-analyzer-hbae-interference-risk-review-chromatograms-carefully. Based on FDA recall #Z-2745-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2745-2018%22&limit=1).
The FDA announced on June 6, 2018, that Tosoh Bioscience Inc recalled G8 Automated HPLC Analyzers due to a hazard where the software may report invalid test results in the presence of HbAE. Owners should exercise caution when reviewing chromatograms and ensure Flag 43 is enabled.
How to tell if you have it
Brand: Tosoh
Product: G8 Automated HPLC Analyzer
Model numbers: HLC-723G8-ST, lot code 021560; HLC-723G8-LA, lot code 021674
Software version: Ver. 5.23
Units affected: 665
The hazard
The hazard involves the HbAE interfering with the HbA1c assay on the current version of software, Ver. 5.23, which could lead to invalid test results being reported.
Context
GovInfoNow's records show Tosoh Bioscience Inc has 19 other recalls on record since June 11, 2017. Other recent recalls of similar products include the Tosoh ST AIA-Pack Test Recall (June 12, 2026), the Tosoh AIA-Pack BHCG Calibrator Recall (August 7, 2020), and the Tosoh AIA-900 Analyzer Recall (May 22, 2020). Other recent recalls of similar products include the Siemens Atellica CH A1c_E Test Recall (June 8, 2026), the Siemens Atellica CH A1c_E Hemoglobin Test recall (February 23, 2026), and the Nova Biomedical StatStrip Glucose Meter Software Issue recall (July 29, 2026).
How to tell if you have this one
Check for the model numbers HLC-723G8-ST (021560) or HLC-723G8-LA (021674) on the device. The device must have software version 5.23 installed to be affected.
Brand
Tosoh
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Settings
Ensure Flag 43 is enabled in the software to avoid invalid test results when HbAE is present in blood samples.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide Distributed - US Nationwide. and the countries of Foreign distribution to Brazil, Caribbean, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Panama, Peru, and Uruguay.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2745-2018 (June 6, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2745-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.