Home › Device types › DKJ
Colorimetry, Salicylate
FDA product code DKJ · Class 2 · Clinical Toxicology
21
Registered devices
14
Adverse events
6
Recalls
29
510(k) clearances
Devices with this code
SAL — RANDOX LABORATORIES LIMITEDAtellica CH Salicylate (SalC) — Siemens Healthcare Diagnostics Inc.Dimension® Flex® reagent cartridge SAL — Siemens Healthcare Diagnostics Inc.ADVIA® Chemistry SAL Salicylate Reagents — Siemens Healthcare Diagnostics Inc.Salicyclate — Roche Diagnostics GmbHSALICYLATE-SL Assay — SEKISUI DIAGNOSTICS, LLCSalicylate Assay — SEKISUI DIAGNOSTICS, LLCARCHITECT — ABBOTT LABORATORIESSalicylate — Roche Diagnostics GmbHSyva® Emit® tox™ Salicylic Acid Assay — Siemens Healthcare Diagnostics Inc.Salicylate — Roche Diagnostics GmbHDRI Salicylate Calibrator Kit — Microgenics CorporationARCHITECT — ABBOTT LABORATORIESVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Alinity — ABBOTT LABORATORIESDimension Vista® Flex® reagent cartridge SAL — Siemens Healthcare Diagnostics Inc.Synchron — Beckman Coulter, Inc.Emit® tox™ Salicylic Acid Assay — Siemens Healthcare Diagnostics Inc.DRI Salicylate Serum Tox Assay — Microgenics CorporationSalicylate Liqui-UV® — STANBIO LABORATORY, L.P.Atellica CH Sal — Siemens Healthcare Diagnostics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-06-29 | Siemens Healthcare Diagnostics, Inc. | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine |
| 2017-04-03 | Beckman Coulter Inc. | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result |
| 2016-07-25 | Microgenics Corporation | Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL. |
| 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. |
| 2007-10-22 | Beckman Coulter Inc | The Salicylate Reagent lots listed here may fail calibration and/or fail to maintain linearity at the upper end of analytical range. |
| 2006-12-05 | Diagnostic Chemicals, Ltd. | Upon subsequent testing on different instruments (as required by other customers), DCL detected a non-linear response on certain analyzers. A decision was made |
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