DRG Salivary Testosterone ELISA Recalled for Inaccurate Low-Range Results
DRG Instruments GmbH is recalling 38 kits of Salivary Testosterone ELISA because the assay may report testosterone levels that are too low.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is limited to inaccurate diagnostic results in a specific range, which aligns with the criteria for moderate severity involving low-risk issues or voluntary precautionary measures without reported harm.
Plain-English summary
DRG Instruments GmbH is recalling 38 kits of the Salivary Testosterone ELISA (Catalog # SLV-3013). The recall involves lot numbers 66K118 and 66K019. The product is an enzymatic in vitro assay used to detect testosterone in human saliva, primarily for fertility studies.
The recall was initiated because the salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results that are too low. Specifically, saliva samples in the low measuring range of the kit (less than 50 pg/ml) were assayed significantly lower than expected.
The affected products were distributed worldwide, including nationwide in the United States (specifically California and Michigan) and in Canada, Brazil, China, and Poland. Users of the affected kits should stop using them and contact the manufacturer for further instructions.
The recalled product
- 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 measure
- Manufacturer
- DRG Instruments GmbH
- Hazard
- Affected units
- 38
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Numbers: 66K118
- 66K019
Distribution
Related recalls
Same manufacturer · DRG Instruments GmbH
See all →- ModerateDRG Salivary Progesterone ELISA Kit Recalled for Low Result Bias
FDA (Devices) · 2019-09-04
- ModerateDRG Instruments Recalls Salivary Estradiol ELISA Kits Due to Measurement Errors
FDA (Devices) · 2018-08-22
Same hazard · inaccurate results
See all →- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
- Highepoc BGEM BUN Test Card for epoc Blood Analysis System
FDA (Devices) · 2026-05-06
- HighAbbott i-STAT EG7+ Blood Gas Cartridges Reporting Inaccurate Results
FDA (Devices) · 2026-05-06