# FDA recall Z-0259-2025

> **Princeton Biomeditech Corp** · Class II · device recall initiated 2024-08-23.

## Product

Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy.  Model/Catalog Number: 1004

## Reason for recall

This recall was initiated due to customer complaints of false negative of hCG test results when running patient urine samples. Use of the above listed product lot may result in false negative results. An end user reported that the OSOM Ultra hCG Combo Test, lot 563L13, produced false negative test results from 2 patient urine samples as confirmed by quantitative hCG and ultrasound. During further root cause testing and investigation, an additional 6 devices were found to produce false negative test results from hCG positive samples.

## Distribution

US Distribution to MO only.

## Key facts

- **Recall number:** Z-0259-2025
- **Recalling firm:** Princeton Biomeditech Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-23
- **Report date:** 2024-11-06

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0259-2025

## Citation

> AI Analytics. FDA recall Z-0259-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0259-2025. Source: US FDA. Licensed CC0.

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