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Recall Observatory FDA recall evidence

Device product

ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240

Z-0826-2018

February 13, 2018

Class II

Product summary

Firm
Tosoh Bioscience Inc
Event
Event 79176
Status
Terminated
Classification
Class II
Quantity
3322
Official record key
device-enforcement:Z-0826-2018

Official wording

Reason: 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.

Code information: All lots

Distribution pattern: Distributed in 39 states: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.