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Total Bilirubin LiquiColor®
STANBIO LABORATORY, L.P. · Model 0230-450 · UDI-DI 00657498000588
JFM
Prescription
10
510(k) clearances
31
Adverse events
9
Recalls
6
Facilities
Description
The Stanbio Total Bilirubin LiquiColor® test system is a device intended to measure the levels of bilirubin (total) in serum and plasma. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-10-11 | Randox Laboratories Ltd. | Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method. |
| 2023-07-10 | Siemens Healthcare Diagnostics, Inc. | Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atell |
| 2023-07-10 | Siemens Healthcare Diagnostics, Inc. | Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atell |
| 2023-07-10 | Siemens Healthcare Diagnostics, Inc. | Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atell |
| 2023-07-10 | Siemens Healthcare Diagnostics, Inc. | Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atell |
| 2020-02-13 | Siemens Healthcare Diagnostics, Inc. | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy |
| 2020-02-13 | Siemens Healthcare Diagnostics, Inc. | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy |
| 2020-02-13 | Siemens Healthcare Diagnostics, Inc. | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy |
| 2020-02-13 | Siemens Healthcare Diagnostics, Inc. | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy |
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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.