Home › Device types › CGZ
Electrode, Ion-Specific, Chloride
FDA product code CGZ · Class 2 · Clinical Chemistry
480
Registered devices
158
Adverse events
11
Recalls
38
510(k) clearances
Devices with this code
NOVA — NOVA BIOMEDICAL CORPORATIONABL80 SC80 — Radiometer Medical ApSEPOC READER, REFURBISHED — Epocal IncNOVA — NOVA BIOMEDICAL CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONGEM Premier 5000 PAK BG/ISE/COOX 75 TEST — INSTRUMENTATION LABORATORY COMPANYABL90 FLEX, Clot catcher — Radiometer Medical ApSMembrane for E755 electrode — Radiometer Medical ApSDisposable Waste Container D512 REF 905-590 — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSGEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 300 TEST — INSTRUMENTATION LABORATORY COMPANYSensor Module Cl- — Siemens Healthcare Diagnostics Inc.Ready Sensor™ GOLD Reference Sensor — Siemens Healthcare Diagnostics Inc.ISE ELECTROLYTE REFERENCE 88811 — CAROLINA LIQUID CHEMISTRIES CORPORATIONABL90 FLEX PLUS — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSRAPIDLab® 1200 Na+/K+/Ca++/CL- Electrode Fill — Siemens Healthcare Diagnostics Inc.RAPIDLab® 1200 Series 1245 — Siemens Healthcare Diagnostics Inc.GEM Premier 5000 PAK BG/ISE/GL/COOX 300 TEST — INSTRUMENTATION LABORATORY COMPANYAccessories starter kit for ABL800 FLEX — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSARCHITECT — ABBOTT LABORATORIESMembrane for E733 electrode — Radiometer Medical ApS
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-09-10 | Ortho-Clinical Diagnostics | Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge. |
| 2019-09-10 | Ortho-Clinical Diagnostics | Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge. |
| 2018-08-28 | Abbott Laboratories, Inc | There is a potential to generate falsely elevated serum or plasma chloride results when using the product. |
| 2018-07-11 | Ortho-Clinical Diagnostics | The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the |
| 2018-07-11 | Ortho-Clinical Diagnostics | The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for urine samples. The measuring r |
| 2011-03-15 | OPTI Medical Systems, Inc | The values reported by the chloride sensors may report erroneous values below specification on aqueous controls and potentially with patient samples of whole bl |
| 2009-04-20 | OPTI Medical Systems, Inc | Outer box labeling shows an incorrect storage temperature range. |
| 2008-05-23 | Abbott Laboratories, Inc | Software defect can allow tests ordered for one sample to be aspirated from a different sample, reporting erroneous results for the affected sample. |
| 2007-09-26 | Abbott Laboratories, Inc | Quality Control (Out of Range)- ICT Calibrator lot number: 0505017, may contain an interferent. Not all vials within a kit are affected. The investigation de |
| 2005-02-01 | Radiometer America Inc | The CI membrane units generate too low values for status and sensitivity during calibration. |
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