FDA-Device2018-03-07Class II
ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
Tosoh Bioscience Inc
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.
Sold states
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.
Affected count
3322
Manufactured in
3600 Gantz Rd, N/A, Grove City, OH, United States
Products
ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0826-2018Don't want to check this manually?
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