Reported Sep 4, 2019 · Terminated

DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro…

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 · N/A

Is this the product you have?

  • DRG Salivary Progesterone HS ELISA- IVD for the determination
  • of progesterone in human saliva REFSLV-5911 in vitro diagnostic
Lot codes and dates
  • Lot Number315K029
Amount recalled
8 Kits

Why it was recalled

Salivary Progesterone assay may observe a higher percentage of samples with low results. Saliva samples in the low measuring range of the kit {< 20 pg/ml) were assayed and producing a significantly lower result.

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 May 11, 2020 · Data as of Sep 19, 6:18 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.