Tosoh Bioscience recalls ST-AIA CEA assay kits with part number 025254 due to potential false test results from Asfotase Alfa (Strensiq) interference. All lot codes affected.
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Tosoh Bioscience is recalling ST-AIA CEA assay kits with part number 025254 because they may give false high or low results when used with Asfotase Alfa (Strensiq) medication. This could lead to incorrect cancer marker testing.
The assay kits may produce inaccurate test results when used with Asfotase Alfa (Strensiq) medication. This could cause false high or low readings of tumor markers, potentially leading to incorrect cancer treatment decisions.
People using ST-AIA CEA assay kits with part number 025254 for tumor marker testing who are also taking Asfotase Alfa (Strensiq). Those most at risk are patients undergoing cancer monitoring with this medication.
Check for the ST-AIA CEA assay kit with part number 025254. All lot codes are affected, so any kit with this part number is included in the recall.
Verify the part number on your ST-AIA CEA assay kit; if it's 025254, it's affected.
No, the recall does not require stopping use. The kits may give false results when used with Asfotase Alfa (Strensiq), but the remedy is not stated.
The recall does not specify a remedy, so no action is required beyond checking if you have the affected part number.
This is a potential accuracy issue, not a safety hazard. The recall focuses on false test results, not physical harm.
We’ve drafted a message you can send Tosoh Biosc: Inc to request your refund or repair — edit it as you like.
Subject: Recall Z-2066-2018 — Tosoh Biosc: Inc Tosoh Biosc: Inc Hello, I own a Tosoh Biosc: Inc that is covered by recall Z-2066-2018 from Tosoh Biosc: Inc. 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.
