Device product
ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239
Z-0825-2018
Product summary
- Event
- Event 79176
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5579
- Official record key
device-enforcement:Z-0825-2018
Official wording
Reason: 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.
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.
Derived failure modes
-
Unknown
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.