Fremont, CA, US · 6 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| LFH | U.V. Spectrometry, Tricyclic Antidepressant Drugs | Class II | Clinical Toxicology | 2 | 2023-11-17 |
| JXM | — | — | — | 1 | 2024-12-11 |
| DKZ | — | — | — | 1 | 2024-10-30 |
| DJG | Enzyme Immunoassay, Opiates | Class II | Clinical Toxicology | 1 | 2023-09-27 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Class II | Clinical Toxicology | 1 | 2021-09-24 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-10-01 | Class II | Ongoing | Z-0415-2026 | Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OC… | — | The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may l… |
| 2022-01-20 | Class II | Ongoing | Z-1284-2022 | QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567… | — | Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result values when us… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-12-11 | K243498 | Alinity c Benzodiazepines Reagent Kit | JXM | — | — |
| 2024-10-30 | K240670 | DRI Ecstasy Plus Assay | DKZ | — | — |
| 2023-11-17 | K231020 | Alinity c Tricyclic Antidepressants Reagent Kit | LFH | Class II | Clinical Toxicology |
| 2023-09-27 | K231007 | CEDIA Heroin Metabolite (6-AM) Assay | DJG | Class II | Clinical Toxicology |
| 2022-12-21 | K213875 | DRI TM Tricyclics Serum Tox Assay | LFH | Class II | Clinical Toxicology |
| 2021-09-24 | K211973 | DRI Cocaine Metabolite Assay | DIO | Class II | Clinical Toxicology |