Tosoh recalls HbA1c Control kits for inaccurate diabetes test results. Affected kits may give wrong blood sugar readings, causing health risks. Stop using immediately.
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
Tosoh is recalling HbA1c Control kits that could produce incorrect blood sugar test results. This might lead to wrong diabetes management decisions if used without proper calibration.
The test kits can give falsely high or low HbA1c readings. This means blood sugar levels might be misinterpreted, leading to incorrect diabetes treatment decisions.
People using HbA1c Control kits for diabetes testing may be affected. Those with diabetes who rely on these kits for monitoring are most at risk.
Check for the product name 'Tosoh ST AIA-PACK HbA1c Control' with part number PN 025418. All lots of this product are affected.
Look for the product name and part number PN 025418 on the kit packaging.
If you have the affected kit, do not use it for diabetes testing until a replacement is obtained.
The recall is happening because the HbA1c Control kits can produce inaccurate blood sugar test results, which could lead to incorrect diabetes management.
Check for the product name 'Tosoh ST AIA-PACK HbA1c Control' with part number PN 025418. All lots of this product are affected.
If you have the affected kit, stop using it immediately and contact Tosoh for a replacement or alternative solution.
We’ve drafted a message you can send Tosoh to request your refund or repair — edit it as you like.
Subject: Recall Z-1811-2018 — Tosoh Tosoh Hello, I own a Tosoh that is covered by recall Z-1811-2018 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.
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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.
