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CEDIA Digitoxin Assay
Microgenics Corporation · Model 100004 · UDI-DI 00884883005648
1
510(k) clearances
156
Adverse events (1 deaths)
5
Recalls
16
Facilities
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 the specific assay an |
| 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 type for VITROS DGXN Sl |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.