Tosoh Bioscience Recalls Progesterone II Assay Kits Due to Cross-Reactivity
Tosoh Bioscience is recalling ST AIA-PACK Prog II assay kits because DHEA-S supplements can cause falsely elevated progesterone results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (misdiagnosis) due to inaccurate test results, fitting the criteria for a High severity score.
Plain-English summary
Tosoh Bioscience Inc is recalling 5,579 units of the ST AIA-PACK Prog II, Progesterone II Assay (Part Number: 025239). The recall covers all lots of this specific product.
The recall was initiated because the assay produces 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 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. Users should stop using the affected kits and contact Tosoh Bioscience for instructions on return or replacement.
The recalled product
- Product
- ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 5,579
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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