Home › Device types › LFM
Enzyme Immunoassay, Digitoxin
FDA product code LFM · Class 2 · Clinical Toxicology
10
Registered devices
156
Adverse events
5
Recalls
20
510(k) clearances
Devices with this code
IMMULITE 2000 Sytems Digitoxin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE/IMMULITE 1000 Digitoxin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCEDIA Digitoxin Assay — Microgenics CorporationDimension® Flex® reagent cartridge DGTX — Siemens Healthcare Diagnostics Inc.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.ADVIA Centaur® DGTN +Z — Siemens Healthcare Diagnostics Inc.Dimension Vista® Flex® reagent cartridge DGTX — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® DGTN — Siemens Healthcare Diagnostics Inc.Atellica IM Dgtn — Siemens Healthcare Diagnostics Inc.Atellica IM Dgtn — Siemens Healthcare Diagnostics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-05 | QUIDEL ORTHO | Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results. |
| 2024-12-05 | QUIDEL ORTHO | Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results. |
| 2013-06-12 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
| 2012-11-14 | Siemens Healthcare Diagnostics, Inc | Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on t |
| 2012-06-28 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics revised the VITROS Chemistry Products DGXN Slides Instructions for Use (IFU) and removed heparin plasma as a recommended specimen typ |
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