# FDA recall Z-0825-2018

> **Tosoh Bioscience Inc** · Class II · device recall initiated 2018-02-13.

## Product

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

## 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.

## Distribution

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.

## Key facts

- **Recall number:** Z-0825-2018
- **Recalling firm:** Tosoh Bioscience Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-13
- **Report date:** 2018-03-07
- **Termination date:** 2020-10-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Grove City, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0825-2018

## Citation

> AI Analytics. FDA recall Z-0825-2018. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0825-2018. Source: US FDA. Licensed CC0.

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