Drug recall
DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in…
FDA recall event 83177 · Class II · DRG Instruments GmbH
Key facts
| Event ID | 83177 |
|---|---|
| Recall numbers | Z-2410-2019 |
| Recalling firm | DRG Instruments GmbH |
| Product type | Devices |
| Products | DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jun 6, 2019 |
| Report date | Sep 4, 2019 |
| Termination date | May 11, 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: