Tosoh Bioscience recalls ST AIA-PACK PROG III assay (part 025240) due to false high progesterone readings from DHEA-S cross-reactivity. Affected units may give inaccurate test results.
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 III assay (part number 025240) because it can produce false high progesterone results when used with certain DHEA supplements. This could lead to incorrect medical decisions if the test is used for pregnancy or hormone monitoring.
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 medical conclusions.
Users of this progesterone test kit, particularly those monitoring hormone levels or pregnancy, may get inaccurate results if they use the kit with DHEA supplements. People taking DHEA supplements are at higher risk of false readings.
Check for the part number 025240 on the ST AIA-PACK PROG III assay kit. All lots of this specific product are affected.
Look for the part number 025240 on the ST AIA-PACK PROG III assay kit.
The assay can produce false high progesterone results due to cross-reactivity with DHEA-S from DHEA supplements.
No action is required beyond checking if you have the affected kit. The recall does not require immediate discontinuation.
Check the part number on your kit. If it's 025240, you may want to contact Tosoh Bioscience for guidance.
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-0826-2018 — Tosoh Biosc: Inc Tosoh Biosc: Inc Hello, I own a Tosoh Biosc: Inc that is covered by recall Z-0826-2018 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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