Drug recall
DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product…
FDA recall event 83183 · Class II · DRG Instruments GmbH
Key facts
| Event ID | 83183 |
|---|---|
| Recall numbers | Z-2159-2019 |
| Recalling firm | DRG Instruments GmbH |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | May 21, 2019 |
| Report date | Aug 14, 2019 |
| Termination date | May 29, 2020 |
| City | Marburg |
| Country | Germany |
| FEI number | 3002800697 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: