DRG International, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0258-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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 Classification:

Class III

Date Initiated: September 13, 2024

Date Posted: November 6, 2024

Recall Number: Z-0258-2025

Event ID: 95429

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.

Status: Ongoing

Product Quantity: 504 units

Code Information:

Lot Code: 04048474012927 (DRG Instruments GmbH) lots: 22K024 and 22K034

Distribution Pattern:

AZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy Netherlands Poland Romania Russia Singapore Spain Tunesia Vietnam

Voluntary or Mandated:

Voluntary: Firm initiated