Reported Aug 22, 2018 · Terminated

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

DRG Instruments GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: DRG Instruments GmbH · Frauenbergstr. 18 · Marburg · N/A

Is this the product you have?

  • Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
Lot codes and dates
  • Lot # 68K056 Exp. Date 2017-05
Amount recalled
169 kits

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 4, 2020 · Data as of Sep 19, 4:46 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.