FDA Device Intelligence
Home › Device types › MQM

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

ABL90 FLEX, Clot catcher — Radiometer Medical ApSMembrane for E755 electrode — Radiometer Medical ApSDisposable Waste Container D512 REF 905-590 — Radiometer Medical ApSGEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 300 TEST — INSTRUMENTATION LABORATORY COMPANYAccessories starter kit for ABL800 FLEX — Radiometer Medical ApSMembrane for E733 electrode — Radiometer Medical ApSCalibration Solution 1 — Radiometer Medical ApS925-047 ABL90 FLEX inlet clip — Radiometer Medical ApSABL90 Sensor Cassette pack — Radiometer Medical ApS905-918 ABL90 FLEX flush device — Radiometer Medical ApSCrea Calibration Solution 2 — Radiometer Medical ApSADVIA® Chemistry Total Bilirubin_2 TBIL_2 Reagents — Siemens Healthcare Diagnostics Inc.Cleaning Solution with additive S8375 REF 944-126 — Radiometer Medical ApSMembrane for E1001 electrode — Radiometer Medical ApSARCHITECT — Abbott GmbHCalibration gas 1 — Radiometer Medical ApSCalibration Solution — Radiometer Medical ApSCalibration Gas 2 — Radiometer Medical ApSMembrane for E722 electrode — Radiometer Medical ApSGEM Premier 5000 PAK BG/ISE/COOX/TBILI 150 TEST — INSTRUMENTATION LABORATORY COMPANYElectrode for ABL analyzers — Radiometer Medical ApSMembrane for E744 electrode — Radiometer Medical ApSARCHITECT — ABBOTT IRELANDARCHITECT — ABBOTT LABORATORIES

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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.