Tosoh Bioscience recalls ST-AIA PACK PAP (Part 025262) due to potential false assay results in prostate tests. Affected units may need to be replaced to ensure accurate test results.
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 PAP (Part Number 025262) for prostate assays because it can cause false high or low test results. This means test accuracy could be compromised if the product is used without replacement.
The ST-AIA PACK PAP can interfere with certain prostate assays, leading to false increased or decreased test results. This may cause incorrect conclusions about test outcomes.
Users of prostate assays with the ST-AIA PACK PAP (Part 025262) are affected. Those performing these tests are most at risk of inaccurate results.
Check for the ST-AIA PACK PAP with Part Number 025262 in prostate assays. All lot codes are affected by this recall.
Identify if your prostate assay kit has the ST-AIA PACK PAP with Part Number 025262.
The ST-AIA PACK PAP can cause false high or low test results in prostate assays, which may lead to inaccurate test outcomes.
Look for the ST-AIA PACK PAP with Part Number 025262 in prostate assays; all lot codes are affected.
The recall does not specify a remedy, so check with Tosoh Bioscience for guidance on next steps.
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-2068-2018 — Tosoh Biosc: Inc Tosoh Biosc: Inc Hello, I own a Tosoh Biosc: Inc that is covered by recall Z-2068-2018 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.
