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

FDA product code CHL · Class 2 · Clinical Chemistry

697
Registered devices
2,392
Adverse events
184
Recalls
188
510(k) clearances

Devices with this code

Stat Profile — NOVA BIOMEDICAL CORPORATIONReady Sensor™ GOLD Electrode pCO2 — Siemens Healthcare Diagnostics Inc.ABL80 SC80 — Radiometer Medical ApSS8377 REF 944-136 *6 Cleaning solution Met II Solution — Radiometer Medical ApSGEM 4000 PAK BG ISE GL COOX BILI 150 TEST 30 DAY — INSTRUMENTATION LABORATORY COMPANYABL80 SC80 — Radiometer Medical ApSStat Profile — NOVA BIOMEDICAL CORPORATIONOPTI Analyzer CCA TS — OPTI MEDICAL SYSTEMS, INC.Stat Profile — NOVA BIOMEDICAL CORPORATIONGEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 450 TEST — INSTRUMENTATION LABORATORY COMPANYStat Profile — NOVA BIOMEDICAL CORPORATIONGEM Premier 5000 PAK BG COOX (150 TEST) — INSTRUMENTATION LABORATORY COMPANYGEM Premier 5000 PAK BG/ISE/GL/COOX 75 TEST — INSTRUMENTATION LABORATORY COMPANYGEM Premier 5000 PAK BG ISE GL COOX TBILI (75 TEST) — INSTRUMENTATION LABORATORY COMPANYEPOC HOST 2, CA — Epocal IncRAPIDLab® 348 Wash — Siemens Healthcare Diagnostics Inc.GEM Premier 7000 with iQM3 PAK (BG/COOX 300 Tests) — INSTRUMENTATION LABORATORY COMPANYSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONStat Profile — NOVA BIOMEDICAL CORPORATIONHOST 2, EPOC, JAPANESE — Epocal IncGEM 4000 PAK BG ISE GL COOX 600 TEST 21 DAY — INSTRUMENTATION LABORATORY COMPANYGEM 4000 PAK BG COOX BILI 75 TEST 30 DAY — INSTRUMENTATION LABORATORY COMPANYGEM Premier 7000 with iQM3 PAK (BG/ISE/COOX/Tbili 150 Tests) — INSTRUMENTATION LABORATORY COMPANYSTAT PROFILE — NOVA BIOMEDICAL CORPORATION

Recent recalls

DateFirmReason
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
2026-05-21Instrumentation LaboratoryThe active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malf
2026-05-08Instrumentation LaboratoryBCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incor
2026-05-08Instrumentation LaboratoryBCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incor
2026-05-08Instrumentation LaboratoryBCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incor
2026-05-08Instrumentation LaboratoryBCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incor
2026-05-08Instrumentation LaboratoryBCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incor
2026-05-08Instrumentation LaboratoryBCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incor
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
2026-04-01Abbott Point Of Care Inc.Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cart

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