Home › Device types › DIP
Enzyme Immunoassay, Diphenylhydantoin
FDA product code DIP · Class 2 · Clinical Toxicology
28
Registered devices
905
Adverse events
11
Recalls
44
510(k) clearances
Devices with this code
Atellica CH Phny — Siemens Healthcare Diagnostics Inc.Alinity — ABBOTT LABORATORIESDimension® Flex® reagent cartridge PTN — Siemens Healthcare Diagnostics Inc.ONLINE TDM Phenytoin — Roche Diagnostics GmbHADVIA® Chemistry PHNY_2 Phenytoin_2 Reagents — Siemens Healthcare Diagnostics Inc.Phenytoin — Roche Diagnostics GmbHSyva® Emit® 2000 Phenytoin Calibrators — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® PHTN Calibrator — Siemens Healthcare Diagnostics Inc.IMMULITE® 2000 Systems PHN Phenytoin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDPHT — RANDOX LABORATORIES LIMITEDADVIA Centaur® Systems, ACS:180® Systems PHTN Calibrator — Siemens Healthcare Diagnostics Inc.ONLINE TDM Phenytoin — Roche Diagnostics GmbHADVIA Centaur® PHTN — Siemens Healthcare Diagnostics Inc.Phenytoin — Roche Diagnostics GmbHADVIA Centaur® PHTN MCM — Siemens Healthcare Diagnostics Inc.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.IMMULITE®/IMMULITE® 1000 Systems PHN Phenytoin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDARCHITECT — ABBOTT LABORATORIESADVIA Centaur® PHTN — Siemens Healthcare Diagnostics Inc.IMMULITE® Systems SDC CONTROL Serum Drug Control Module — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDSyva® Emit® 2000 Phenytoin Assay — Siemens Healthcare Diagnostics Inc.Dimension Vista® Flex® reagent cartridge PTN — Siemens Healthcare Diagnostics Inc.ONLINE TDM Phenytoin — Roche Diagnostics GmbHEmit® 2000 Phenytoin Assay — Siemens Healthcare Diagnostics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-01-14 | Ortho-Clinical Diagnostics, Inc. | A deformity affecting a specific lot of VITROS Chemistry Products VersaTips. Deformed VersaTips results may be biased by up to +/-16% for both immunometric and |
| 2018-05-09 | Ortho-Clinical Diagnostics | There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than exp |
| 2017-06-12 | Ortho-Clinical Diagnostics | The firm identified the potential for biased results to be generated when processing VITROS PHYT Slide product with citrate plasma specimen samples. The curren |
| 2014-09-24 | Siemens Healthcare Diagnostics, Inc. | Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with this lot resulting in the potential for a positive or negative |
| 2014-08-20 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics identified a potential for biased results to be generated when using VITROS PHYT Slides, Lot 2613-0150-4913. Some positively biased |
| 2013-12-18 | Siemens Healthcare Diagnostics, Inc | ADVIA Centaur Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to reco |
| 2013-12-18 | Siemens Healthcare Diagnostics, Inc | ADVIA Centaur Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to reco |
| 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. |
| 2008-02-15 | Abbott Laboratories Inc. | An Abbott investigation has determined that the phenytoin reagent does not maintain an onboard stability of 28 days as stated in the phenytoin package insert. |
| 2004-06-18 | Roche Diagnostics Corp. | May report falsely decreased patient results. |
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