---
title: "Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of h... — FDA record Z-0259-2025 | Is It on Recall"
description: "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 l"
url: https://isitonrecall.com/recall/fda-device-z-0259-2025-osom-ultra-hcg-combo-test-ivd-immunoassay-for-the-qualitative-detection-of-human-chorionic-gonadotro/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in ser... — FDA record Z-0259-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Aug 23, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: 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.
- **Classification**: Class II
- **Recalling firm**: Princeton Biomeditech Corp
- **Quantity**: 1,860 kits (50,220 test devices)
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0259-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0259-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI-DI: 00742860100208 Lot Number: 563L13 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US Distribution to MO only.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Missouri](https://isitonrecall.com/state/missouri/)

## Dates in the source

- **Report date**: Nov 6, 2024
- **Recall initiation date**: Aug 23, 2024
- **Center classification date**: Oct 30, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0259-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Princeton Biomeditech Corp records](https://isitonrecall.com/brand/princeton-biomeditech-corp/)