DRG Instruments GmbH: Medical Device Recall in 2018 - (Recall #: Z-2836-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 14, 2016

Date Posted: August 22, 2018

Recall Number: Z-2836-2018

Event ID: 80575

Reason for Recall:

Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1.

Status: Terminated

Product Quantity: 169 kits

Code Information:

Lot # 68K056 Exp. Date 2017-05

Distribution Pattern:

NJ; Germany, Belgium, Spain & Germany

Voluntary or Mandated:

Voluntary: Firm initiated