FDAMay 21, 2019device
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 ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
What to do
FDA enforcement status: Terminated
Brands named
drg instrumentsdrg
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAeTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-1582026-03-02
- FDAeTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-1592026-03-02
- FDAeTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-1562026-03-02
- FDAeTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-1512026-03-02
- FDAeTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-1572026-03-02
- FDAeTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-1522026-03-02
- FDAeTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-1502026-03-02
- FDAeTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-1492026-03-02
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →