FDA Medical Device Recalls (openFDA)
DRG Instruments GmbH: DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means
- Recall number
- Z-2159-2019
- Recalling firm
- DRG Instruments GmbH
- Product
- DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means
- Status
- Terminated
- Initiated
- 2019-05-21
- Posted
- not on file
- Terminated
- 2020-05-29
- Reason
- 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
- Root cause
- Under Investigation by firm
- Action
- DRG International issued notification via email on 5/21/19 advising of the problem, health risk and action to take: 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 lots and request they fill out the form and return at once.5. Patient samples that have been determined with the affected lots 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 drqsupport@drginternational.com).
- Quantity
- 38 kits
- Distribution
- Worldwide Distribution - US Nationwide CA, MI Foreign: Canada, Brazil, China, Poland
- Lot, serial or model codes
- Lot Numbers: 66K118, 66K019
- 510(k) numbers
- ["K052649"]
- PMA numbers
- not on file
- Product code
- CDZ
- Firm FEI
- 3002800697
- Firm city
- Marburg
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28