Tosoh Bioscience recalls ST AIA-PACK PROG II Progesterone II Assay (part 025239) due to false high progesterone readings from DHEA-S cross-reactivity. All lots affected.
Falsely elevated progesterone assay values will occur when using certain progesterone assay part numbers due to cross reactivity of DHEA-S, a metabolite of the DHEA (dehydroepiandrosterone) supplement.
Tosoh Bioscience is recalling its ST AIA-PACK PROG II Progesterone II Assay (part number 025239) because it can give false high progesterone results when used with DHEA supplements. This could lead to incorrect health decisions if the test is used for medical purposes.
The assay cross-reacts with DHEA-S, a metabolite found in DHEA supplements. This causes the test to show higher progesterone levels than actually present, potentially leading to incorrect health conclusions.
Users of this specific progesterone assay kit who take DHEA supplements may get false high results. Healthcare providers using the kit for patient testing are most at risk of misdiagnosis.
Check if you have the ST AIA-PACK PROG II Progesterone II Assay with part number 025239. All lots of this product are affected.
Identify if your kit has part number 025239. All lots are affected.
The assay cross-reacts with DHEA-S, a metabolite in DHEA supplements, causing false high progesterone readings.
No, but you should check if you have the affected part number. If you do, you may need to use a different test.
This could lead to incorrect health decisions if used for medical purposes, but it does not cause direct 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-0825-2018 — Tosoh Biosc: Inc Tosoh Biosc: Inc Hello, I own a Tosoh Biosc: Inc that is covered by recall Z-0825-2018 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.
