Marburg, N/A, Germany
DRG Instruments GmbH recalls
3 recalls recorded since 2018, most recently on 6 June 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 6 June 2019
- Terminated
- 11 May 2020
- 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.
- Distribution
- Distribution to Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2410-2019
- DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
Terminated Class II Medical devices
- Recall started
- 21 May 2019
- Terminated
- 29 May 2020
- Reason
- 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
- Distribution
- Worldwide Distribution - US Nationwide CA, MI Foreign: Canada, Brazil, China, Poland
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2159-2019
- DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of T
Terminated Class II Medical devices
- Recall started
- 14 July 2016
- Terminated
- 4 August 2020
- Reason
- Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1.
- Distribution
- NJ; Germany, Belgium, Spain & Germany
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2836-2018
- Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.