Tosoh Bioscience recalls ST-AIA PACK Testosterone (Part 025204) due to potential false test results. Affected units may cause inaccurate hormone 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 its ST-AIA PACK Testosterone assay kit (Part Number 025:204) because it can produce false high or low results when used with Asfotase Alfa (Strensiq) treatments. This could lead to incorrect hormone level assessments for patients.
The assay kit can produce inaccurate test results when used with Asfotase Alfa (Strensiq) treatments. This may cause false high or low readings of testosterone levels, potentially leading to incorrect medical decisions.
Patients using this testosterone assay kit with Asfotase Alfa (Strensiq) treatments may be affected. Those with specific medical conditions requiring precise hormone monitoring are most at risk.
Check for the ST-AIA PACK Testosterone assay kit with Part Number 025204. All lot codes are affected. This product is sold by Tosoh Bioscience.
Verify the product name and part number on the kit to confirm it matches the recalled ST-AIA PACK Testosterone (Part 025204).
The recall specifically addresses the testosterone assay kit used with Strensiq treatments. If you use this kit with Strensiq, you may need to switch to an alternative test.
The affected kit has the ST-AIA PACK Testosterone name and Part Number 025204. All lot codes are included in this recall.
The recall does not specify a remedy or action for affected kits. Check with Tosoh Bioscience for guidance on alternative testing options.
We’ve drafted a message you can send Tosoh Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-2093-2018 — Tosoh Bioscience Tosoh Bioscience Hello, I own a Tosoh Bioscience that is covered by recall Z-2093-2018 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.
