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Electrode, Ion Based, Enzymatic, Creatinine

FDA product code CGL · Class 2 · Clinical Chemistry

123
Registered devices
195
Adverse events
9
Recalls
8
510(k) clearances

Devices with this code

S8377 REF 944-136 *6 Cleaning solution Met II Solution — Radiometer Medical ApSSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONStatSensor/StatStrip — NOVA BIOMEDICAL CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONStat Profile — NOVA BIOMEDICAL CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONNOVA — NOVA BIOMEDICAL CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONCalibration gas 1 — Radiometer Medical ApSElectrode for ABL analyzers — Radiometer Medical ApSNOVA — NOVA BIOMEDICAL CORPORATIONABL800 FLEX — Radiometer Medical ApSSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONCalibration Solution 2 — Radiometer Medical ApSStatSensor/StatStrip — NOVA BIOMEDICAL CORPORATIONStat Profile — NOVA BIOMEDICAL CORPORATIONNOVA — NOVA BIOMEDICAL CORPORATIONNOVA — NOVA BIOMEDICAL CORPORATIONNOVA — NOVA BIOMEDICAL CORPORATIOND8088+D8089 Crea membrane A+B — Radiometer Medical ApSSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONRinse Solution II S4987 REF 944-155 600mL — Radiometer Medical ApSStatSensor/StatStrip — NOVA BIOMEDICAL CORPORATION

Recent recalls

DateFirmReason
2025-04-24Mckesson Medical-Surgical Inc. Corporate Officetransit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage con
2014-10-29Radiometer America IncNegative drift on QC during in-use lifetime of CREA membranes can be observed.
2011-12-16Radiometer America IncWhen the user activates the dosicap (containing the crea additive) and mounts it onto the bottle, the threads will not seal correctly causing approximately 10%
2010-03-17Abbott Point of Care Inc.The i-STAT CREA Cartridges may produce inaccurate (depressed) results at or near the end of the labeled expiry date when stored above 25 degrees for 2 weeks.
2009-03-26Radiometer America IncAnalysis of customer data, (for ABL 8X7 customers) has shown that the reference membranes are out of analytical specifications when replaced as specified in the
2008-08-11Nova Biomedical CorporationErroneous, low creatinine results on CCX analyzer
2007-11-02Nova Biomedical CorporationIncorrect Results - Creatinine results were lower than the laboratory reference method.
2007-11-02Nova Biomedical CorporationIncorrect Results - Creatinine results were lower than the laboratory reference method.
2007-11-02Nova Biomedical CorporationIncorrect Results - Creatinine results were lower than the laboratory reference method.

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