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.
Tosoh is recalling two models of HPLC analyzers that use software version 5.23. HbAE in blood samples can cause invalid diabetes test results if Flag 43 isn't enabled in the software. This means users might get incorrect diabetes readings if they don't adjust the settings.
HbAE (a type of hemoglobin) can interfere with the HbA1c test results when using software version 5.23. If Flag 43 isn't enabled, the device may report invalid results for people with HbAE in their blood. This could lead to incorrect diabetes diagnoses or monitoring.
People using the HLC-723G8-ST (021560) or HLC-723G8-LA (021674) analyzers with software version 5.23. Those testing for diabetes with HbAE in their blood are most at risk of inaccurate results.
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.
Ensure Flag 43 is enabled in the software to avoid invalid test results when HbAE is present in blood samples.
HbAE can cause invalid diabetes test results if Flag 43 isn't enabled in software version 5.23.
No, but you must check software settings to avoid inaccurate results.
Ensure Flag 43 is enabled in the software to prevent invalid test results.
We’ve drafted a message you can send Tosoh to request your refund or repair — edit it as you like.
Subject: Recall Z-2745-2018 — Tosoh Tosoh Hello, I own a Tosoh that is covered by recall Z-2745-2018 from Tosoh. 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.
