Tosoh Bioscience Inc recalls ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239

Recall date

February 13, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0825-2018

FDA classification

Class II

Brand / firm

Tosoh Bioscience Inc

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239