DRG Salivary Progesterone HS ELISA- IVD for the determination of… — Class II medical device recall Z-2410-2019
Terminated recall by DRG Instruments GmbH, reported 2019-09-04. Salivary Progesterone assay may observe a higher percentage of samples with low results. Saliva samples in the
| Recall number | Z-2410-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DRG Instruments GmbH, Marburg, N/A, Germany |
| Recall initiated | 2019-06-06 |
| Classified | 2019-08-27 |
| Reported by FDA | 2019-09-04 |
| Terminated | 2020-05-11 |
| Countries outside the US | CA |
| Quantity | 8 kits |
| Reason classes | potency |
| Lot numbers | 315K029 |
| Model numbers | SLV-5911 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2410-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.