Home › Device types › DLZ
Enzyme Immunoassay, Phenobarbital
FDA product code DLZ · Class 2 · Clinical Toxicology
23
Registered devices
409
Adverse events
9
Recalls
35
510(k) clearances
Devices with this code
Alinity — ABBOTT LABORATORIESIMMULITE®/IMMULITE® 1000 Systems PHE Phenobarbital — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDEmit® 2000 Phenobarbital Assay — Siemens Healthcare Diagnostics Inc.Phenobarbital — Roche Diagnostics GmbHCEDIA Phenobarbital II Assay — Microgenics CorporationVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.ARCHITECT — ABBOTT LABORATORIESPhenobarbital — Roche Diagnostics GmbHDimension Vista® Flex® reagent cartridge PHNO — Siemens Healthcare Diagnostics Inc.ONLINE TDM Phenobarbital — Roche Diagnostics GmbHONLINE TDM Phenobarbital — Roche Diagnostics GmbHDimension® Flex® reagent cartridge PHNO — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIESPHB — RANDOX LABORATORIES LIMITEDADVIA Centaur® Systems Phenobarbital Calibrator — Siemens Healthcare Diagnostics Inc.Syva® Emit® 2000 Phenobarbital Assay — Siemens Healthcare Diagnostics Inc.Atellica CH Phnb — Siemens Healthcare Diagnostics Inc.IMMULITE® 2000 Systems PHE Phenobarbital — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDADVIA Centaur® Systems, ACS:180® Systems PHNB Calibrator — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIESSyva® Emit® 2000 Phenobarbital Calibrators — Siemens Healthcare Diagnostics Inc.ADVIA® Chemistry PHNB_2 Phenobarbital_2 Reagents — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® PHNB — Siemens Healthcare Diagnostics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-08-30 | Siemens Healthcare Diagnostics, Inc. | Imprecision with certain lots |
| 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. |
| 2013-03-14 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of e |
| 2012-12-10 | Siemens Healthcare Diagnostics, Inc. | Firm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and the Syva(R) Emit(R) 2000 Phenobarbital (4D019UL) lots E1, E2, |
| 2012-11-16 | Abbott Laboratories, Inc | Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to imprecision issues which increase with the age of t |
| 2012-07-30 | Siemens Healthcare Diagnostics, Inc. | Firm has confirmed highter imprecision with the recalled lots on Beckman Coulter AU(R) Systems. Also, if the Syva(R) Emit(R) 2000 Phenobartbital Assay (4D019UL |
| 2011-06-23 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in control fluid values when using various lots o |
| 2009-08-11 | Beckman Coulter Inc. | The recall was initiated because Beckman Coulter has confirmed reports of variability in results with the lots of Phenobarbital (PHE) reagent and calibrator. |
| 2006-09-26 | Abbott Laboratories Inc. | Erratic elevated results and or the inability to calibrate due to imprecision. |
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