DRG International recalls Salivary Testosterone ELISA model SLV-3013 due to invalid controls causing repeated tests and delayed patient results. Affected units have specific lot numbers.
Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating the runs and delays for reporting results to patients.
DRG International recalls their Salivary Testosterone ELISA model SLV-3013 because the Low Control is out of range, causing invalid test results and delays in reporting to patients. This affects labs using the product for testosterone testing.
The Low Control in the test kit is out of range, meaning it produces results that are too high. This causes the test to be invalid, requiring the lab to repeat the test and delay patient results.
Labs using the Salivary Testosterone ELISA model SLV-3013 for testosterone testing are affected. Lab technicians and healthcare providers who rely on this product for patient results are most at risk.
Check for the model number SLV-3013 on the product. Affected units have lot numbers 66K014 or 66K123. The product is used for saliva testosterone testing in labs.
Look for lot numbers 66K014 or 66K123 on the product packaging.
The Low Control in the test kit is out of range, causing invalid test results and delays in reporting to patients.
Check the lot number on the product. If it's 66K014 or 66K123, contact DRG International for guidance.
No, the hazard only causes delayed test results, not physical injury.
We’ve drafted a message you can send DRG International to request your refund or repair — edit it as you like.
Subject: Recall Z-2622-2024 — DRG International DRG International Hello, I own a DRG International that is covered by recall Z-2622-2024 from DRG International. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
