FDA Device recall Z-2836-2018
Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in sal…
- FDA Device
- Class II
- terminated
- Published 2018-08-22
On 2018-08-22 the FDA classified a Class II recall of Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in sal… by Drg Instruments, citing lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2836-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-14 |
| Published | 2018-08-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Drg Instruments |
| Distribution | NJ |
Product
Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
Reason
Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1.
Identifiers
| code_info | Lot # 68K056 Exp. Date 2017-05 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2836-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.