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Enzyme Immunoassay, Carbamazepine
FDA product code KLT · Class 2 · Clinical Toxicology
27
Registered devices
54
Adverse events
5
Recalls
56
510(k) clearances
Devices with this code
Atellica CH Carb — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott GmbHEmit® 2000 Carbamazepine Assay — Siemens Healthcare Diagnostics Inc.IMMULITE® / IMMULITE® 1000 Systems CMP Carbamazepine — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDSyva® Emit® II Plus Barbiturate Assay — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIESONLINE TDM Carbamazepine Gen4 — Roche Diagnostics GmbHIMMULITE® 2000 Systems CMP Carbamazepine — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDADVIA Centaur® CARB MCM — Siemens Healthcare Diagnostics Inc.Synchron — Beckman Coulter, Inc.Syva® Emit® II Plus Barbiturate Assay — Siemens Healthcare Diagnostics Inc.Dimension Vista® Flex® reagent cartridge CRBM — Siemens Healthcare Diagnostics Inc.ONLINE TDM Carbamazepine Gen.4 — Roche Diagnostics GmbHVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.CBZ — RANDOX LABORATORIES LIMITEDARCHITECT — Abbott GmbHADVIA Centaur® CARB +Z — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott GmbHDimension® Flex® reagent cartridge CRBM — Siemens Healthcare Diagnostics Inc.Carbamazepine — Roche Diagnostics GmbHSyva® Emit® Carbamazepine Assay — Siemens Healthcare Diagnostics Inc.CEDIA Carbamazepine II Assay — Microgenics CorporationADVIA Centaur® CARB — Siemens Healthcare Diagnostics Inc.Syva® Emit® Carbamazepine Calibrators — Siemens Healthcare Diagnostics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-03-05 | Ortho-Clinical Diagnostics | The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides, Lot 3920-0080-8403. |
| 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. VITROS CRBM Slid |
| 2005-05-26 | Ortho-Clinical Diagnostics | Falsely elevated Carbamazepine results. |
| 2003-11-17 | Abbott Laboratories HPD/ADD/GPRD | The package inserts contain incorrect values for the alternate unit (mol/L) Control Ranges |
| 2003-06-11 | Beckman Coulter Inc | Product was found to produce higher recoveries by about 7-12% compared to other lots. |
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