DRG recalls salivary progesterone test kits for potential low results in saliva samples. This in vitro diagnostic kit may produce inaccurate low readings for samples under 20 pg/ml.
Salivary Progesterone assay may observe a higher percentage of samples with low results. Saliva samples in the low measuring range of the kit {< 20 pg/ml) were assayed and producing a significantly lower result.
DRG is recalling salivary progesterone test kits that may show lower results than expected for certain saliva samples. This could lead to incorrect hormone level assessments, especially for samples with very low progesterone.
The test kit may produce significantly lower results for saliva samples with progesterone levels below 20 pg/ml. This could lead to incorrect hormone assessments, but does not cause physical harm or injury.
People using DRG Salivary Progesterone HS ELISA kits for at-home hormone testing may be affected. Those testing saliva samples with very low progesterone levels (under 20 pg/ml) are most at risk of inaccurate results.
Check for the kit's reference number SLV-5911 and lot number 315K029 on the packaging. This in vitro diagnostic kit is sold for determining progesterone in human saliva.
Look for the reference number SLV-5911 and lot number 315K029 on the product packaging.
The kit may produce significantly lower results for saliva samples with progesterone levels below 20 pg/ml, potentially leading to inaccurate hormone assessments.
Check the product packaging for the reference number SLV-5911 and lot number 315K029. No specific action is required beyond checking the kit details.
No, the recall is for potential inaccurate test results, not a physical hazard or injury risk.
We’ve drafted a message you can send DRG to request your refund or repair — edit it as you like.
Subject: Recall Z-2410-2019 — DRG DRG Hello, I own a DRG that is covered by recall Z-2410-2019 from DRG. 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.
