FDA Device recall Z-2410-2019
DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
- FDA Device
- Class II
- terminated
- Published 2019-09-04
On 2019-09-04 the FDA classified a Class II recall of DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic by Drg Instruments, citing 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 produci….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2410-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-06 |
| Published | 2019-09-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Drg Instruments |
| Distribution | n/a |
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.
Identifiers
| code_info | Lot Number:315K029 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2410-2019%22
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