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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