Recall Z-2410-2019— DRG Instruments GmbH
Class II · Terminated
Class II FDA medical device recall by DRG Instruments GmbH, initiated 2019-06-06, terminated 2020-05-11. FDA's recall record names no specific 510(k) clearance for this event. Product: DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic. Reason: 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..
- Recalling firm
- DRG Instruments GmbH
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-06-06
- Terminated
- 2020-05-11
- Firm location
- Marburg, N/A, Germany
Product description
DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.