DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
Brand
DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany
Lot Codes / Batch Numbers
Lot Number:315K029
Products Sold
Lot Number:315K029
DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany is recalling DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
DRG International issued notification letter via email dated 5/22/19 advising of the problem, health risk and Action to be taken by Distributors and End-users: 1. We kindly ask you to immediately examine your stock and promptly quarantine these products. 2. Please send back or discard all unused kits 3. Please use the attached response form, fill, sign and send back to us 4. Please inform your customers and forward this letter and notice to persons who received the affected lot and request they fill out the form and return at once. 5. Patient samples that have been determined with the affected lot should be checked again carefully. If results are lower than expected samples should be re-run again. 6. Please tell us if you have experienced any problem with this lot and specify the details. Reply to DRG (email: qa@drg-international.com and copy drgsupport.@drginternational.com).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026