Monmouth Junction, NJ, US · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| SCA | Multi-Analyte Respiratory Virus Antigen Detection Test | Class II | Microbiology | 1 | 2025-11-14 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-08-23 | Class II | Ongoing | Z-0259-2025 | Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum … | — | 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… |