FDA recall Z-2159-2019

Product

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

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-05-21

Report date

2019-08-14

Termination date

2020-05-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marburg, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2159-2019