Salivary Testosterone ELISA Quality Control Failure Invalidates Test Results
DRG International is recalling Salivary Testosterone ELISA kits (Model SLV-3013) due to out-of-range quality controls that invalidate test runs and delay patient results. The recall affects 257 units distributed nationwide in six states.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: FDA Class III medical device with a quality control defect that invalidates test runs and delays patient reporting, with no reported illnesses or injuries. The recall is precautionary to ensure diagnostic test reliability.
Plain-English summary
DRG International is recalling Salivary Testosterone ELISA (Model SLV-3013), an in vitro diagnostic test for measuring free active testosterone in saliva samples. A total of 257 units have been distributed nationwide in California, Illinois, Minnesota, Pennsylvania, Utah, and Virginia.
The recall is due to invalid quality controls. The Low Control value is out of range (too high), causing test runs to fail and invalidate results. This forces laboratories to repeat testing, which delays the reporting of results to patients. The affected lot numbers are 66K014 and 66K123.
Laboratories using affected kits should contact DRG International regarding further instructions and corrective actions.
The recalled product
- Product
- Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.
- Manufacturer
- DRG International, Inc.
- Affected units
- 257
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 (3)
- Model/Catalog Number: SLV-3013
- UDI-DI: 04048474030136
- Lot Nymbers: 66K014 and 66K123.
Distribution
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