DRG Instruments recalls salivary testosterone test kit SLV-3013 for potential low results in low testosterone samples. Affected units have lot numbers 66K118 or 6:6K019.
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
DRG Instruments recalls their salivary testosterone test kit (SLV-301:3) because it may show lower results than actual for samples with very low testosterone levels. This could lead to inaccurate fertility assessments in medical testing.
The test kit may show results too low for samples with testosterone levels below 50 pg/ml. This could lead to incorrect fertility assessments if the test is used for medical purposes without proper interpretation.
Men and women undergoing fertility studies who use this specific salivary testosterone test kit may be affected. Those with very low testosterone levels are at slightly higher risk of inaccurate results.
Check for the product name 'Salivary Testosterone ELISA' and catalog number SLV-3013. Affected units have lot numbers 66K118 or 66K019.
Verify the catalog number is SLV-3013 and lot number is 66K118 or 66K019.
The test kit may show results too low for samples with testosterone levels below 50 pg/ml, potentially leading to inaccurate fertility assessments.
Check the lot number on the kit. If it's 66K118 or 66K019, contact DRG Instruments for guidance.
No, this is a potential accuracy issue for medical testing, not a safety hazard.
We’ve drafted a message you can send DRG Instruments to request your refund or repair — edit it as you like.
Subject: Recall Z-2159-2019 — DRG Instruments DRG Instruments Hello, I own a DRG Instruments that is covered by recall Z-2159-2019 from DRG Instruments. 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.
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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.
