# FDA recall Z-0258-2025

> **DRG International, Inc.** · Class III · device recall initiated 2024-09-13.

## 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

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-0258-2025
- **Recalling firm:** DRG International, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-13
- **Report date:** 2024-11-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Springfield, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0258-2025

## Citation

> AI Analytics. FDA recall Z-0258-2025. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0258-2025. Source: US FDA. Licensed CC0.

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