Ortho-Clinical Diagnostics recalls VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic

Recall date

May 9, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2344-2018

FDA classification

Class II

Brand / firm

Ortho-Clinical Diagnostics

Sold / distributed

Worldwide distribution. US nationwide, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, and Sweden

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic