Recall Z-0825-2018— Tosoh Bioscience Inc
Class II · Terminated
Class II FDA medical device recall by Tosoh Bioscience Inc, initiated 2018-02-13, terminated 2020-10-29. FDA's recall record names no specific 510(k) clearance for this event. Product: ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239. 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..
- Recalling firm
- Tosoh Bioscience Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-02-13
- Terminated
- 2020-10-29
- Firm location
- Grove City, OH, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.