DRG Instruments GmbH recalls DRG Salivary Progesterone HS ELISA- IVD for the determinatio
Recalled Product
DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
Hazard / Issue
Salivary Progesterone assay may observe a higher percentage of samples with low results. Saliva samples in the low measuring range of the kit {< 20 pg/ml) were assayed and producing a significantly lower result.
Issued by
FDA
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