Z-0826-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 7, 2018
- Initiation Date
- February 13, 2018
- Termination Date
- October 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3322
Product Description
ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
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