Home / Recalls / DRG Instruments GmbH / Z-2410-2019

Z-2410-2019 Class II Terminated

Recalled by DRG Instruments GmbH — Marburg, N/A

Recall Details

Product Type: Devices
Report Date: September 4, 2019
Initiation Date: June 6, 2019
Termination Date: May 11, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8 Kits

Product Description

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

Reason for Recall

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.

Distribution Pattern

Distribution to Canada

Code Information

Lot Number:315K029