Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative… — Class II medical device recall Z-0259-2025
Ongoing recall by Princeton Biomeditech Corp, reported 2024-11-06. This recall was initiated due to customer complaints of false negative of hCG test results when running patien
| Recall number | Z-0259-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Princeton Biomeditech Corp, Monmouth Junction, NJ, United States |
| Recall initiated | 2024-08-23 |
| Classified | 2024-10-30 |
| Reported by FDA | 2024-11-06 |
| UPC / GTIN / UDI-DI | 00742860100208 |
| Lot numbers | 563L13 |
| Model numbers | 1004 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0259-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.