Salivary Estradiol ELISA — Class II medical device recall Z-2836-2018
Terminated recall by DRG Instruments GmbH, reported 2018-08-22, distributed in NJ. Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1.
| Recall number | Z-2836-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DRG Instruments GmbH, Marburg, Germany |
| Recall initiated | 2016-07-14 |
| Classified | 2018-08-16 |
| Reported by FDA | 2018-08-22 |
| Terminated | 2020-08-04 |
| Distributed | NJ |
| Countries outside the US | BE, DE, ES |
| Quantity | 169 kits |
| Lot numbers | 2017-05, 68K056 |
| Model numbers | LV-4188 |
Product
Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
Reason for recall
Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1.
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-2836-2018. 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.