Tosoh Bioscience Recalls ST AIA-PACK Progesterone III Assay Kits
Tosoh Bioscience is recalling ST AIA-PACK Progesterone III Assay kits because cross-reactivity with DHEA-S supplements can cause falsely elevated test results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves inaccurate test results (falsely elevated values) due to cross-reactivity, which is a significant quality issue but does not involve direct physical injury or death, fitting the Moderate severity criteria for labeling/accuracy errors.
Plain-English summary
Tosoh Bioscience Inc is recalling 3,322 units of the ST AIA-PACK Progesterone III Assay (Part Number: 025240). The recall affects all lots of this specific product.
The recall was initiated because the assay may produce falsely elevated progesterone values when used on samples from individuals taking DHEA (dehydroepiandrosterone) supplements. This occurs due to cross-reactivity with DHEA-S, a metabolite of the DHEA supplement.
The affected products were distributed in 39 states, including AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI. Healthcare facilities and laboratories should stop using the affected kits and contact Tosoh Bioscience for instructions on returning the product.
The recalled product
- Product
- ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 3,322
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Part of a larger recall action
This product is one of 2 recalled by Tosoh Bioscience Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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