DRG International, Inc. has recalled 257 units of the Salivary Testosterone ELISA diagnostic kit (Model SLV-3013). This medical device is an enzyme immunoassay used by laboratories to measure testosterone levels in saliva samples. The recall was initiated because the 'Low Control' component in specific lots is testing too high and is out of the required range. This defect causes the entire diagnostic run to be invalid, leading to the need for repeat testing and potentially delaying critical results for patients.
The invalid control levels prevent laboratories from verifying the accuracy of the test. This results in testing delays and the need for repeat analysis, which can delay patient diagnosis and clinical decision-making.
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Sources: FDA iRES · Raw API Response
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