Device recall

Z-2836-2018: Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative…

FDA device recall · Class II · DRG Instruments GmbH

Key facts

Recall number (Z-number) Z-2836-2018
Recall event 80575
Product Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
Product code PEJ
Recalling firm DRG Instruments GmbH
Recall class Class II
Status Terminated
Termination date Aug 4, 2020
FEI number 3002800697

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)