Home › Device types › CGZ
Electrode, Ion-Specific, Chloride
FDA product code CGZ · Class 2 · Clinical Chemistry
471
Registered devices
157
Adverse events
11
Recalls
38
510(k) clearances
Devices with this code
Ready Sensor™ GOLD Electrode pCO2 — Siemens Healthcare Diagnostics Inc.ABL80 SC80 — Radiometer Medical ApSNova — NOVA BIOMEDICAL CORPORATIONS8377 REF 944-136 *6 Cleaning solution Met II Solution — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSGEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 450 TEST — INSTRUMENTATION LABORATORY COMPANYGEM Premier 5000 PAK BG/ISE/GL/COOX 75 TEST — INSTRUMENTATION LABORATORY COMPANYEPOC HOST 2, CA — Epocal IncRAPIDLab® 348 Wash — Siemens Healthcare Diagnostics Inc.NOVA — NOVA BIOMEDICAL CORPORATIONPHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.HOST 2, EPOC, JAPANESE — Epocal IncSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONABL80 SC80 — Radiometer Medical ApSARCHITECT — ABBOTT LABORATORIESNova — NOVA BIOMEDICAL CORPORATIONABL80 SC80 — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSGL Cartridge — LifehealthGENCHEM™ ISE Electrolyte Reference — GENCHEM INCABL80 SC80 — Radiometer Medical ApSCL ELECTRODE, ISE MODULE — Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagABL80 SC80 — Radiometer Medical ApSSTAT PROFILE — NOVA BIOMEDICAL CORPORATION
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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