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ONLINE TDM Phenytoin
Roche Diagnostics GmbH · Model 08445567190 · UDI-DI 07613336157787
DIP
Prescription
2
510(k) clearances
905
Adverse events
11
Recalls
22
Facilities
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 competitive assays. |
| 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 expected results for bo |
| 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 current Instructions for U |
| 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 bias and imprecisio |
| 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 results were identif |
| 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 recoveries using previou |
| 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 recoveries using previou |
| 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. In addition, the 14 |
| 2004-06-18 | Roche Diagnostics Corp. | May report falsely decreased patient results. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.