Z-2836-2018Class II

Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol...

Name: Z-2836-2018 Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol...
Creator: DRG Instruments GmbH
Published: 2016-07-14
License: https://open.fda.gov/license/

DRG Instruments GmbH / initiated 2016-07-14 / Terminated / root cause: manufacturing process

FDA source

DRG Instruments GmbH began a recall of Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva on 2016-07-14. FDA classified it as Class II and gives the reason as "Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2836-2018
Classification: Class II
Status: Terminated
Initiated: 2016-07-14
Posted: 2018-08-16
Terminated: 2020-08-04
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.
Product code: PEJ Salivary Estriol Test
Reason for recall: Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1.
Root cause tag: manufacturing process
FDA 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 in commerce: 169 kits
Distribution: NJ; Germany, Belgium, Spain & Germany
Product codes and lots: Lot # 68K056 Exp. Date 2017-05

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2836-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2836-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16

Product code PEJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)