Tosoh Bioscience Inc: Medical Device Recall in 2018 - (Recall #: Z-0825-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 13, 2018

Date Posted: March 7, 2018

Recall Number: Z-0825-2018

Event ID: 79176

Reason for Recall:

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.

Status: Terminated

Product Quantity: 5579

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.

Voluntary or Mandated:

Voluntary: Firm initiated