FDA Device recall Z-2159-2019
DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testoste…
- FDA Device
- Class II
- terminated
- Published 2019-08-14
On 2019-08-14 the FDA classified a Class II recall of DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testoste… by Drg Instruments, citing 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)….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2159-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-21 |
| Published | 2019-08-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Drg Instruments |
| Distribution | US |
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
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
Identifiers
| code_info | Lot Numbers: 66K118, 66K019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2159-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.