DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany
Lot Codes / Batch Numbers
Lot Numbers: 66K118, 66K019
Products Sold
Lot Numbers: 66K118, 66K019
DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany is recalling DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3 due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
DRG International issued notification via email on 5/21/19 advising of the problem, health risk and action to take: 1. We kindly ask you to immediately examine your stock and promptly quarantine these products, 2. Please send back or discard all unused kits. 3. Please use the attached response form, fill, sign and send back to us.4. Please inform your customers and forward this letter and notice to persons who received the affected lots and request they fill out the form and return at once.5. Patient samples that have been determined with the affected lots should be checked again carefully. If results are lower than expected samples should be re-run again. 6. Please tell us if you have experienced any problem with this lot and specify the details. Reply to DRG (email: qa@drg-international.com and copy drqsupport@drginternational.com).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026