Tosoh recalls HbA1c Pretreatment Solution (PN 025718) due to potential for inaccurate blood sugar test results. Affected users should contact for guidance.
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
Tosoh is recalling its HbA:1c Pretreatment Solution (PN 025718) because it may cause blood sugar test results to be too high or too low. This could lead to incorrect diabetes management decisions.
The product may produce inaccurate HbA1c results, which are used to measure long-term blood sugar control. Incorrect results could lead to improper diabetes treatment decisions.
People using this product for diabetes testing are affected. Those with diabetes who rely on HbA1c tests for management are most at risk.
Check for the product name 'Tosoh ST AIA-PACK HbA1c Pretreatment Solution' or model number PN 025718. The product is sold for in vitro diagnostic use only.
Reach out to Tosoh Bioscience Inc for guidance on next steps.
The product may cause inaccurate HbA1c results, so it is not recommended for use without guidance from the manufacturer.
Contact Tosoh Bioscience Inc for specific instructions on how to handle the product.
The manufacturer recommends contacting them for guidance before continuing use.
We’ve drafted a message you can send Tosoh to request your refund or repair — edit it as you like.
Subject: Recall Z-1812-2018 — Tosoh Tosoh Hello, I own a Tosoh that is covered by recall Z-1812-2018 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.
