DRG Instruments GmbH: Medical Device Recall in 2019 - (Recall #: Z-2410-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 6, 2019

Date Posted: September 4, 2019

Recall Number: Z-2410-2019

Event ID: 83177

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.

Status: Terminated

Product Quantity: 8 Kits

Code Information:

Lot Number:315K029

Distribution Pattern:

Distribution to Canada

Voluntary or Mandated:

Voluntary: Firm initiated