Z-2410-2019Class II

DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911...

Name: Z-2410-2019 DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911...
Creator: DRG Instruments GmbH
Published: 2019-06-06
License: https://open.fda.gov/license/

DRG Instruments GmbH / initiated 2019-06-06 / Terminated

FDA source

DRG Instruments GmbH began a recall of DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic on 2019-06-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2410-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-06
Posted: 2019-08-28
Terminated: 2020-05-11
Recalling firm: DRG Instruments GmbH
Product: DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
Product code: JLS Radioimmunoassay, Progesterone
Reason for recall: 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.
FDA root cause: Under Investigation by firm
Action: 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: [email protected] and copy [email protected]).
Quantity in commerce: 8 Kits
Distribution: Distribution to Canada
Product codes and lots: Lot Number:315K029

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2410-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2410-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27

Product code JLS

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)