Tosoh G8 HPLC Analyzer Recall: Software Lacks 510K for Diabetic Testing
Tosoh recalls G8 HPLC analyzers with software missing a 510K clearance for hemoglobin A1c testing in diabetes diagnosis. Affected units have specific serial numbers listed.
Recall notice
Analyzers were distributed with software which lacks a 510K
Contact the company
What happened, in plain English
Tosoh is recalling G8 Automated HPLC Analyzers that were sold with software lacking a required 510K clearance. This could affect the accuracy of hemoglobin A1c tests used for diabetes diagnosis. Affected units have specific serial numbers listed in the recall. Read more at govinfonow.com/recall/70606-tosoh-g8-hplc-analyzer-recall-software-lacks-510k-for-diabetic.
Source Summary by GovInfoNow · govinfonow.com/recall/70606-tosoh-g8-hplc-analyzer-recall-software-lacks-510k-for-diabetic · Updated August 20, 2026 · FDA enforcement record: FDA #Z-3244-2018
Cite this page
“Tosoh G8 HPLC Analyzer Recall: Software Lacks 510K for Diabetic Testing.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70606-tosoh-g8-hplc-analyzer-recall-software-lacks-510k-for-diabetic. Based on FDA recall #Z-3244-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3244-2018%22&limit=1).
Why it’s dangerous
The software lacks a 510K clearance, which is a regulatory approval required for medical devices in the U.S. This could lead to inaccurate hemoglobin A1c results, potentially affecting diabetes diagnosis and treatment decisions.
Who’s affected
Healthcare providers using the G8 analyzers for hemoglobin A1c testing in diabetes diagnosis are likely affected. Patients relying on these tests for diabetes management may be at risk if the analyzer is used without proper software clearance.
How to tell if you have this one
Check if your G8 Automated HPLC Analyzer has serial numbers: 14646304, 14917201, 14886112, 14616503, 14856212, 14887601, 14886212, or 14917201. The device is used for hemoglobin A1c testing in diabetes diagnosis.
- Brand
Tosoh Biosc: Inc- Category
Medical device
What to do — step by step
Check Serial Numbers
Identify if your analyzer has one of the listed serial numbers: 14646304, 14917201, 14886112, 14616503, 14856212, 14887601, 14886212, or 14917201.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
FDA distribution: “US Nationwide Distribution in states of - CA, OK, VA 7 WI” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Oklahoma, Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-3244-2018 (July 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3244-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.