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Bilirubin (Total And Unbound) In The Neonate Test System

FDA product code MQM · Class 1 · Clinical Chemistry

96
Registered devices
72
Adverse events
6
Recalls
17
510(k) clearances

Devices with this code

S8377 REF 944-136 *6 Cleaning solution Met II Solution — Radiometer Medical ApSGEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 450 TEST — INSTRUMENTATION LABORATORY COMPANYDisposable Waste Container D512 REF 905-590 — Radiometer Medical ApSABL90 FLEX Analyzer — Radiometer Medical ApSCalibration gas 1 — Radiometer Medical ApSElectrode for ABL analyzers — Radiometer Medical ApSABL800 FLEX — Radiometer Medical ApSABL90 Sensor Cassette pack — Radiometer Medical ApSCalibration Solution 2 — Radiometer Medical ApSSC90 50 BG, LYT, MET, OXI + QC — Radiometer Medical ApSDrager Jaundice Meter, model JM-103 — DRAEGER MEDICAL SYSTEMS, INC.Calibration Solution — Radiometer Medical ApSD8088+D8089 Crea membrane A+B — Radiometer Medical ApSGEM Premier 5000 PAK BG/COOX/TBILI 150 TEST — INSTRUMENTATION LABORATORY COMPANYGEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 150 TEST — INSTRUMENTATION LABORATORY COMPANYRinse Solution II S4987 REF 944-155 600mL — Radiometer Medical ApSMembrane for E7066 electrode — Radiometer Medical ApSABL90 FLEX SP90 — Radiometer Medical ApSARCHITECT — ABBOTT IRELANDMembrane for E788 electrode — Radiometer Medical ApSABL90 Sensor Cassette pack — Radiometer Medical ApSMembrane for E733 electrode — Radiometer Medical ApSAlinity — Abbott GmbHCalibration Solution — Radiometer Medical ApS

Recent recalls

DateFirmReason
2018-05-15Draeger Medical Systems, Inc.Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement.
2018-05-15Draeger Medical Systems, Inc.Users have misinterpreted the display for out of range measurement indicated by the blinking "-0-" to mean a zero measurement
2014-12-30Siemens Healthcare Diagnostics IncNeonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the
2014-12-30Siemens Healthcare Diagnostics IncNeonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the
2014-12-30Siemens Healthcare Diagnostics IncNeonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the
2014-12-30Siemens Healthcare Diagnostics IncNeonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.