Z-0825-2018 Class II Terminated
FDA device recall Z-0825-2018 was initiated by Tosoh Bioscience Inc on Feb 13, 2018 and is designated Class II. 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)… The recall status is terminated (terminated Oct 29, 2020). Affected quantity: 5579.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 7, 2018
- Initiation Date
- Feb 13, 2018
- Termination Date
- Oct 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5579
Product Description
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 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.
Code Information
All lots
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0825-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026