Ottawa, CA · 4 510(k) clearances · 3 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OYJ | Dna Specimen Collection, Saliva | Class II | Clinical Chemistry | 2 | 2022-10-27 |
| SIH | Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay | Class II | Microbiology | 1 | 2026-06-10 |
| QPO | — | — | — | 1 | 2021-11-03 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-02-18 | Class II | Ongoing | Z-0982-2022 | ORAcollect RNA: ORE-100 | — | Evaporation of stabilizing liquid reducing shelf life. |
| 2022-02-18 | Class II | Ongoing | Z-0981-2022 | ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.01… | — | Evaporation of stabilizing liquid reducing shelf life. |
| 2020-06-24 | Class III | Terminated | Z-3004-2020 | PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usa… | — | Reagents were shipped to customers after the Use by data indicated on its labeling. |