Enzymatic Method, Bilirubin
Clinical Chemistry · 21 CFR 862.1110
Recent MDR events
31 adverse event reports on file
- ATELLICA VANADATE OXIDASEDec 23, 2025InjurySiemens Healthcare Diagnostics Inc.MW5181105
- ATELLICA CH TOTAL BILIRUBIN_2 (TBIL_2)Sep 13, 2024MalfunctionSiemens Healthcare Diagnostics, Inc.2432235-2024-00206
- ATELLICA CH TOTAL BILIRUBIN_2 (TBIL_2)Jun 23, 2023MalfunctionSiemens Healthcare Diagnostics Inc.2432235-2023-00180
- ATELLICA CH TOTAL BILIRUBIN_2 (TBIL_2)Oct 21, 2021MalfunctionSiemens Healthcare Diagnostics Inc2432235-2021-00261
- ADVIA CHEMISTRY TOTAL BILIRUBIN_2 REAGENTSep 4, 2015MalfunctionSiemens Healthcare Diagnostics Inc.2432235-2015-00386
- ADVIA CHEMISTRY TOTAL BILIRUBIN_2 REAGENTAug 28, 2015MalfunctionSiemens Healthcare Diagnostics Inc.2432235-2015-00380
- UNICEL® DXC 600 SYNCHRON® SYSTEMMar 28, 2012InjuryBeckman Coulter, Inc.2050012-2012-00774
- UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZERAug 7, 2011MalfunctionBeckman Coulter, Inc.2050012-2011-03773
- UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEMAug 3, 2011InjuryBeckman Coulter, Inc.2050012-2011-03822
- UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEMAug 3, 2011InjuryBeckman Coulter, Inc.2050012-2011-03823
Event type breakdown
Recalls
9 recall events for this product code
- Randox Laboratories Ltd.Open, ClassifiedDec 6, 2023
RANDOX Total Bilirubin.
Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
Z-0501-2024 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.Open, ClassifiedAug 28, 2023
Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the
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 Atellica CH Total Bilirubin_2 (TBil_2), AtellicaCH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and AtellicaCH HDL Cholesterol (HDLC)
Z-2471-2023 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.Open, ClassifiedAug 28, 2023
Atellica CH LDL Cholesterol- In vitro diagnostic use in the
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 Atellica CH Total Bilirubin_2 (TBil_2), Atellica CH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and Atellica CH HDL Cholesterol (HDLC)
Z-2472-2023 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.Open, ClassifiedAug 28, 2023
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma (lithi
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 AtellicaCH Total Bilirubin_2 (TBil_2), Atellica CH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and Atellica CH HDL Cholesterol (HDLC)
Z-2473-2023 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.Open, ClassifiedAug 28, 2023
Atellica CH HDL Cholesterol- In vitro diagnostic use in the
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 Atellica CH Total Bilirubin_2 (TBil_2), Atellica CH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and Atellica CH HDL Cholesterol (HDLC)
Z-2474-2023 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedUnknown
Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
Z-1536-2020 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedUnknown
Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
Z-1537-2020 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedUnknown
ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantita
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
Z-1538-2020 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedUnknown
ADVIA Chemistry Total Bilirubin_2 assay-
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
Z-1539-2020 · View FDA record ↗
Registered firms
17 firms currently registered for this product code
510(k) clearances
11 clearances for this product code
- Siemens Healthcare Diagnostics, Inc.Mar 9, 2017
K170065 · ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
- Randox Laboratories LimitedFeb 16, 2016
K152343 · Direct Bilirubin
- Randox Laboratories LimitedJan 28, 2016
K152344 · Total Bilirubin
- Bayer Healthcare, LLCDec 7, 2007
K063845 · ADVIA CHEMISTRY TOTAL BILIRUBIN_2
- Wako Chemicals USA, Inc.Dec 30, 2005
K053132 · WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791
- Wako Chemicals USA, Inc.Dec 30, 2005
K053131 · WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191
- Beckman Coulter, Inc.Dec 16, 2005
K053090 · DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
- Stanbio LaboratoryJun 30, 2005
K050266 · DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR