DRG Instruments GmbH recalls DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro di…

Recall date

June 6, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2410-2019

FDA classification

Class II

Brand / firm

DRG Instruments GmbH

Sold / distributed

Distribution to Canada

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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