Home › Device types › KLS
Enzyme Immunoassay, Theophylline
FDA product code KLS · Class 2 · Clinical Toxicology
24
Registered devices
9
Adverse events
8
Recalls
71
510(k) clearances
Devices with this code
ADVIA Centaur® Systems Calibrator 27 — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIESSynchron — Beckman Coulter, Inc.CEDIA Theophylline II Assay — Microgenics CorporationSyva® Emit® 2000 Theophylline Calibrators — Siemens Healthcare Diagnostics Inc.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Dimension® Flex® reagent cartridge THEO — Siemens Healthcare Diagnostics Inc.THEO — RANDOX LABORATORIES LIMITEDIMMULITE®/IMMULITE® 1000 Systems THE Theophylline — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDADVIA Centaur® THEO 2 — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® THEO 2 — Siemens Healthcare Diagnostics Inc.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Syva® Emit® 2000 Theophylline Assay — Siemens Healthcare Diagnostics Inc.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.ONLINE TDM Theophylline — Roche Diagnostics GmbHSyva® Emit® Caffeine Assay — Siemens Healthcare Diagnostics Inc.Theophylline — Roche Diagnostics GmbHONLINE TDM Theophylline — Roche Diagnostics GmbHEmit® 2000 Theophylline Assay — Siemens Healthcare Diagnostics Inc.ADVIA® Chemistry THEO_2 Theophylline_2 Reagents — Siemens Healthcare Diagnostics Inc.IMMULITE® 2000 Systems THE Theophylline — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDAlinity — ABBOTT LABORATORIESDimension Vista® Flex® reagent cartridge THEO — Siemens Healthcare Diagnostics Inc.Atellica CH Theo — Siemens Healthcare Diagnostics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-11-27 | Siemens Healthcare Diagnostics, Inc. | Lot J1 of the Syva EMIT 2000 Theophylline Assay, when run on a Beckman AU Clinical Chemistry System, may exhibit increased imprecision for commercially availab |
| 2016-06-17 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has confirmed the Syva EMIT 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the ADVIA C |
| 2016-06-17 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has confirmed the Syva EMIT 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the ADVIA C |
| 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. |
| 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. |
| 2012-11-14 | Siemens Healthcare Diagnostics, Inc | Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on t |
| 2012-08-09 | Siemens Healthcare Diagnostics, Inc. | Firm has received complaints from customers of "Abnormal Reaction" errors occurring on calibrations, QC and patient samples. The Abnormal Reaction flag is bein |
| 2003-06-18 | Beckman Coulter Inc | Defective software media distributed with upgrade software may cause installation failure and systems lock. |
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