FDA Medical Device Recalls (openFDA)
DRG Instruments GmbH: Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
- Recall number
- Z-2836-2018
- Recalling firm
- DRG Instruments GmbH
- Product
- Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
- Status
- Terminated
- Initiated
- 2016-07-14
- Posted
- not on file
- Terminated
- 2020-08-04
- Reason
- Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1.
- Root cause
- Nonconforming Material/Component
- Action
- On July 16, 2016, DRG Instruments GmbH emailed customers informing them that they might face a bad differentiation of Standard 0 and Standard 1 Salivary Estradiol kits. Customers were encouraged inspect stock, quarantine and discontinue use of the product. In case the kit was already used, customers were advised to re-check the data and re-run the samples as prevention.
- Quantity
- 169 kits
- Distribution
- NJ; Germany, Belgium, Spain & Germany
- Lot, serial or model codes
- Lot # 68K056 Exp. Date 2017-05
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PEJ
- Firm FEI
- 3002800697
- Firm city
- Marburg
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28