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.
Analyzers were distributed with software which lacks a 510K
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.
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.
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.
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.
Identify if your analyzer has one of the listed serial numbers: 14646304, 14917201, 14886112, 14616503, 14856212, 14887601, 14886212, or 14917201.
The 510K is a U.S. Food and Drug Administration (FDA) clearance for medical devices. This recall indicates the software lacks this required clearance, which could affect test accuracy.
Inaccurate hemoglobin A1c results could lead to incorrect diabetes diagnosis or management, potentially impacting patient care.
The recall does not specify a remedy, so affected users should check their serial numbers and contact Tosoh Bioscience for further instructions.
We’ve drafted a message you can send Tosoh Biosc: Inc to request your refund or repair — edit it as you like.
Subject: Recall Z-3244-2018 — Tosoh Biosc: Inc Tosoh Biosc: Inc Hello, I own a Tosoh Biosc: Inc that is covered by recall Z-3244-2018 from Tosoh Biosc: Inc. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
