Z-2159-2019Class II

DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013

Name: Z-2159-2019 DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013
Creator: DRG Instruments GmbH
Published: 2019-05-21
License: https://open.fda.gov/license/

DRG Instruments GmbH / initiated 2019-05-21 / Terminated

FDA source

DRG Instruments GmbH began a recall of DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA... on 2019-05-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2159-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-21
Posted: 2019-08-05
Terminated: 2020-05-29
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
Product code: CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Reason for recall: 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
FDA 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: [email protected] and copy [email protected]).
Quantity in commerce: 38 kits
Distribution: Worldwide Distribution - US Nationwide CA, MI Foreign: Canada, Brazil, China, Poland
Product codes and lots: Lot Numbers: 66K118, 66K019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2159-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2159-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-05

Product code CDZ

K052649Class IDrg Slv Testosterone Elisa TestDrg Intl., Inc. / cleared 2006-01-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)