Tosoh Bioscience recalls ST-AIA PACK CA 19-9 assay kits due to potential false test results with certain cancer markers. Affected units may give inaccurate tumor marker measurements.
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 PACK CA 19- 9 assay kits because they can cause false high or low results in cancer marker tests. This could lead to incorrect health decisions if used with Asfotase Alfa (Strensiq) treatments.
The assay kits can produce false high or low results when used with Asfotase Alfa (Strensiq) treatments. This could lead to incorrect cancer marker measurements and potentially wrong health decisions.
People using Tosoh ST-AIA PACK CA 19-9 assay kits with Asfotase Alfa (Strensiq) treatments may be affected. Those with cancer markers being tested are most at risk.
Check for ST-AIA PACK CA 19-9 with Part Number 025271. All lot codes are affected. This product is used for tumor marker assays.
Identify if your kit has Part Number 025271 and is labeled ST-AIA PACK CA 19-9 for tumor marker assays.
The recall is for potential false test results, not a direct safety hazard. It's considered low risk as it doesn't cause injury.
No, but you should check if your kit is affected and contact Tosoh if you have Asfotase Alfa (Strensiq) treatments.
Check for Part Number 025271 and ST-AIA PACK CA 19-9 labeling. All lot codes are affected.
We’ve drafted a message you can send Tosoh Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-2069-2018 — Tosoh Bioscience Tosoh Bioscience Hello, I own a Tosoh Bioscience that is covered by recall Z-2069-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
