Z-0258-2025Class III

17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic...

Name: Z-0258-2025 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic...
Creator: DRG International, Inc.
Published: 2024-09-13
License: https://open.fda.gov/license/

DRG International, Inc. / initiated 2024-09-13 / Open, Classified / root cause: labeling and UDI

FDA source

DRG International, Inc. began a recall of 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or... on 2024-09-13. FDA classified it as Class III and gives the reason as "The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Component labels. Due to the defect, the device failed to...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0258-2025
Classification: Class III
Status: Open, Classified
Initiated: 2024-09-13
Posted: 2024-10-29
Recalling firm: DRG International, Inc.
Product: 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292
Product code: JLX Radioimmunoassay, 17-Hydroxyprogesterone
Reason for recall: The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Component labels. Due to the defect, the device failed to provide results, which may result in a delay in obtaining test results and a remote chance of an adverse health risk.
Root cause tag: labeling and UDI
FDA root cause: Process change control
Action: DRG issued Urgent Field Safety Notification on 9/17/24 via email. Letter states reason for recall, health risk and action to take: Please check your inventory for the respective lot and ensure that the proper acceptance ranges provided below are used to validate the assay. Immediately reply to email: [email protected] to confirm this notice and your compliance.
Quantity in commerce: 504 units
Distribution: AZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy Netherlands Poland Romania Russia Singapore Spain Tunesia Vietnam
Product codes and lots: Lot Code: 04048474012927 (DRG Instruments GmbH) lots: 22K024 and 22K034

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0258-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0258-2025	Class III	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-29

Product code JLX

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)