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DRG Instruments Recalls
3 recalls on record · August 22, 2018 to September 4, 2019 · Medical Devices
Recalls by year
18
19
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 4, 2019Medical DevicesFDA
DRG Instruments GmbH recalls DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitr
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.
August 14, 2019Medical DevicesFDA
DRG Instruments GmbH recalls DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usag
Hazard: Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too low. Saliva samples in the low measuring range of the kit(< 50 pg/ml) were assayed significantly lower
August 22, 2018Medical DevicesFDA
DRG Instruments GmbH recalls Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estroge
Hazard: Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1.