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Tosoh Bioscience Inc recalls ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
Recalled March 7, 2018 · FDA recall Z-0826-2018 · Tosoh Bioscience
Hazard
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. · FDA Class II
Units
3322
Sold at
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.
Description
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.
Product
ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
Manufacturer(s)
Tosoh Bioscience Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →