Tosoh recalls HbA1c Calibrators due to potential for inaccurate blood sugar test results. Affected units may give falsely high or low HbA1c readings.
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
Tosoh is recalling HbA1c Calibrators that could produce inaccurate blood sugar test results. This affects people using these devices for diabetes monitoring, as incorrect readings might lead to improper treatment decisions.
The calibrator might produce test results that are too high or too low. This could lead to incorrect blood sugar management decisions, potentially affecting diabetes treatment.
People using the Tosoh HbA1c Calibrator for diabetes testing may be affected. Those with diabetes who rely on these devices for accurate HbA1c measurements are most at risk.
Check for the product name 'Tosoh ST AIA-PACK HbA1c Calibrator' or model number PN 025318. All lots of this product are affected.
Identify the product name and model number to confirm if it's affected.
The recall does not specify if the product is safe to use; it may produce inaccurate results.
Look for the product name 'Tosoh ST AIA-PACK HbA1c Calibrator' or model number PN 025318. All lots are affected.
The recall does not provide specific action steps; check product details to confirm if affected.
We’ve drafted a message you can send Tosoh to request your refund or repair — edit it as you like.
Subject: Recall Z-1810-2018 — Tosoh Tosoh Hello, I own a Tosoh that is covered by recall Z-1810-2018 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.
