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FDAJune 6, 2019device

DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

drg instrumentsdrg

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic — Recall Details · AllClear