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DRG Instruments GmbH recalls DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitr
Recalled September 4, 2019 · FDA recall Z-2410-2019 · DRG Instruments
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. · FDA Class II
Units
8 Kits
Sold at
Distribution to Canada
Description
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.
Product
DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
Manufacturer(s)
DRG Instruments GmbH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →