DRG Instruments GmbH: Medical Device Recall in 2019 - (Recall #: Z-2159-2019)

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 Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means

Product Classification:

Class II

Date Initiated: May 21, 2019

Date Posted: August 14, 2019

Recall Number: Z-2159-2019

Event ID: 83183

Reason for Recall:

Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too low. Saliva samples in the low measuring range of the kit(< 50 pg/ml) were assayed significantly lower

Status: Terminated

Product Quantity: 38 kits

Code Information:

Lot Numbers: 66K118, 66K019

Distribution Pattern:

Worldwide Distribution - US Nationwide CA, MI Foreign: Canada, Brazil, China, Poland

Voluntary or Mandated:

Voluntary: Firm initiated