Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonad...
FDA Device Recall #Z-0259-2025 — Class II — August 23, 2024
Recall Summary
| Recall Number | Z-0259-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 23, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Princeton Biomeditech Corp |
| Location | Monmouth Junction, NJ |
| Product Type | Devices |
| Quantity | 1,860 kits (50,220 test devices) |
Product Description
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 Pattern
US Distribution to MO only.
Lot / Code Information
UDI-DI: 00742860100208 Lot Number: 563L13
Other Recalls from Princeton Biomeditech Corp
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2307-2012 | Class II | Poly stat Flu A & B Test Manufactured for P... | Mar 9, 2012 |
| Z-2308-2012 | Class II | Status Flu A + B Test Manufactured by Prince... | Mar 9, 2012 |
| Z-2306-2012 | Class II | Orasure QuickFlu Rapid A+B Test Manufactured f... | Mar 9, 2012 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.