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Enzymatic, Carbon-Dioxide
FDA product code KHS · Class 2 · Clinical Chemistry
80
Registered devices
265
Adverse events
7
Recalls
86
510(k) clearances
Devices with this code
CARBON DIOXIDE L3K Assay — SEKISUI DIAGNOSTICS, LLCCAROLINA LIQUID CHEMISTRIES CORP.® CO2 RGT. KIT BL-313 — CAROLINA LIQUID CHEMISTRIES CORPORATIONBicarbonate liquid — Roche Diagnostics GmbHThermo Scientific Infinity™ — Fisher DiagnosticsPiccolo Electrolyte Panel — ABAXIS, INC.Carbon Dioxide Reagent — CLINICAL DIAGNOSTIC SOLUTIONS, INC.Synchron — Beckman Coulter, Inc.ARCHITECT — ABBOTT LABORATORIESAlinity — Abbott GmbHPointe Carbon Dioxide on the BS480 — HORIBA INSTRUMENTS INCORPORATEDCARBON DIOXIDE L3K-C Assay — SEKISUI DIAGNOSTICS, LLCSirrus® Bicarbonate (CO2) LiquiColor® — STANBIO LABORATORY, L.P.Diazyme — DIAZYME LABORATORIES, INC.Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDClearChem Diagnostics Inc. Carbon Dioxide (CO2) — CLEARCHEM DIAGNOSTICS INC.Pointe Scientific, Inc. Carbon Dioxide — HORIBA INSTRUMENTS INCORPORATEDCAROLINA LIQUID CHEMISTRIES CORP.® CO2 RGT. KIT AU-313 — CAROLINA LIQUID CHEMISTRIES CORPORATIONDiazyme — DIAZYME LABORATORIES, INC.Bircarbonate liquid — Roche Diagnostics GmbHPOINTE SCIENTIFIC Carbon Dioxide, Liquid Stable — HORIBA INSTRUMENTS INCORPORATEDPiccolo Basic Metabolic Panel Plus — ABAXIS, INC.ARCHITECT — Abbott GmbHJAS Diagnostics — DREW SCIENTIFIC, INC.ACE — ALFA WASSERMANN, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-14 | Beckman Coulter Ireland, Inc. | Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample. |
| 2023-10-25 | Ortho-Clinical Diagnostics, INc. | Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coating 3598 of VITROS ECO2 slides included carts which may contai |
| 2023-04-05 | Beckman Coulter Inc. | There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures. |
| 2023-04-05 | Beckman Coulter Inc. | There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures. |
| 2023-04-05 | Beckman Coulter Inc. | There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures. |
| 2019-10-23 | Abbott GmBH & Co. KG | Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed into the Alinity c Carbon Dioxide reagent, resulting in the potent |
| 2013-06-12 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
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