DRG International, Inc.: Device Recall

Recall Details

Recall Number

Z-0258-2025

Classification

Class III

Product Type

Device

Recalling Firm

DRG International, Inc.

Status

Ongoing

Date Initiated

09/13/2024

Location

Springfield, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

504 units

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.

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

Distribution Pattern

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

Other Recalls by DRG International, Inc.

• Class III: Low Risk 06/04/2025
  An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the kit by 2 months (i.e., 2026-03-31 instead of 2026-01-31). The expiration dates on the bottle labels were correct (i.e., 2026-01-31).
• Class II: Risk 10/07/2024
  The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-calibration R1 and R2 of the device or find controls out of specification (failed Control High) which causes a delay in results.
• Class III: Low Risk 07/05/2024
  Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating the runs and delays for reporting results to patients.

View all recalls by DRG International, Inc. →