Tosoh recalls diabetes assay kits that may give inaccurate blood test results when used with Asfotase Alfa medication. Affected units include specific lot codes of ST-AIA Pack C-Peptide II.
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Tosoh is recalling diabetes test kits that could give false high or low results when used with certain medications. This affects people using these kits with Asf:otase Alfa (Strensiq) treatments.
The medication Asfotase Alfa can interfere with certain Tosoh diabetes test kits, causing them to show falsely high or low results. This might lead to incorrect health decisions if the test results aren't accurate.
People using Tosoh's ST-AIA Pack C-Peptide II diabetes assay kits with Asfotase Alfa (Strensiq) medication. Those most at risk are patients on this medication who rely on accurate test results.
Check for the product name 'ST-AIA Pack C-Peptide II' with part number 025283. All lot codes of this assay are affected.
Verify if your test results seem unusually high or low when using this kit with Asfotase Alfa medication.
The recall does not require stopping use; it only warns about potential inaccurate results when used with Asfotase Alfa.
Affected kits have the product name 'ST-AIA Pack C-Peptide II' with part number 025283 and any lot code.
The recall does not mention any fix or remedy for this issue.
We’ve drafted a message you can send Tosoh Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-2075-2018 — Tosoh Bioscience Tosoh Bioscience Hello, I own a Tosoh Bioscience that is covered by recall Z-2075-2018 from Tosoh Bioscience. 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.
