Exact FDA event identifier

Event 80575

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: July 14, 2016
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: DRG Instruments GmbH

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2836-2018

Recall number: Z-2836-2018
Initiated: July 14, 2016
Classification: Class II
Status: Terminated
Recalling firm: DRG Instruments GmbH
Quantity: 169 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot # 68K056 Exp. Date 2017-05

Distribution pattern

NJ; Germany, Belgium, Spain & Germany