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Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

FDA product code CHL · Class 2 · Clinical Chemistry

707
Registered devices
2,419
Adverse events
185
Recalls
188
510(k) clearances

Devices with this code

STAT PROFILE — NOVA BIOMEDICAL CORPORATIONABL80 SC80 — Radiometer Medical ApSABL77 Sci — Radiometer Medical ApSStat Profile — NOVA BIOMEDICAL CORPORATIONEPOC READER, REFURBISHED — Epocal IncGEM Premier 5000 PAK BG COOX TBILI (300 TEST) — INSTRUMENTATION LABORATORY COMPANYSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONRAPIDPOINT® 350 Reagent Module — Siemens Healthcare Diagnostics Inc.GEM Premier 5000 PAK BG/ISE/COOX 75 TEST — INSTRUMENTATION LABORATORY COMPANYABL90 FLEX, Clot catcher — Radiometer Medical ApSBG Cartridge — LifehealthMembrane for E755 electrode — Radiometer Medical ApSDisposable Waste Container D512 REF 905-590 — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSDaily Cleaning Solution Kit — MEDICA CORPORATIONGEM Premier 3500 3000 iQM BG HCT (150 TEST) — INSTRUMENTATION LABORATORY COMPANYGEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 300 TEST — INSTRUMENTATION LABORATORY COMPANYGEM Premier 3000 iQM - BG HCT ELECT. - 450 Tests — INSTRUMENTATION LABORATORY COMPANYGEM Premier 7000 with iQM3 PAK (BG/COOX/Tbili 450 Tests) — INSTRUMENTATION LABORATORY COMPANYReady Sensor™ GOLD Reference Sensor — Siemens Healthcare Diagnostics Inc.ABL90 FLEX PLUS — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApS

Recent recalls

DateFirmReason
2026-08-18Radiometer Medical ApSIn vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood
2026-05-21Instrumentation LaboratoryThe active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malf
2026-05-21Instrumentation LaboratoryThe active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specificat
2026-05-08Instrumentation LaboratoryPotential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
2026-05-08Instrumentation LaboratoryPotential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
2026-05-08Instrumentation LaboratoryPotential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
2026-05-08Instrumentation LaboratoryPotential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
2026-05-08Instrumentation LaboratoryPotential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
2026-05-08Instrumentation LaboratoryPotential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
2026-04-02Siemens Healthcare Diagnostics IncUse of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, v

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