Kodak Ektachem Clinical Chemistry Slide Phenytoin

• • Terminated Z-2344-2018 FDA Class II ·initiated 9 May 2018

  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 both quality control samples and patient samples.

• • Terminated Z-0273-2018 FDA Class II ·initiated 12 Jun 2017

  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 Use (IFU) and Assay Summary Chart state serum, heparin plasma, and citrate plasma as acceptable specimen types for use with the PHYT assay.

• • Terminated Z-0202-2016 FDA Class III ·initiated 28 Sep 2015 ·on shared 510(k) K941142

  The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9, Lot 0954.

• • Terminated Z-0007-2015 FDA Class II ·initiated 20 Aug 2014

  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 identified during testing of a different VITROS PHYT Slide lot; the affected slides were not released for distribution. Since Lot 2613-0150-4913 was manufactured in the same event, there is the potential for slides from this lot to also be affected.

• • Terminated Z-0321-2014 FDA Class II ·initiated 12 Jun 2013

  Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K941142 ↗

FDA Product Code

DIP

Device Class

Class II

Regulation

21 CFR Part 862.3350

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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