Ortho Clinical Diagnostics recalls VITROS XT3400 Chemistry System, Product code 6844458

Recall date

July 20, 2020

Source

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

Recall number

Z-2878-2020

FDA classification

Class II

Brand / firm

Ortho Clinical Diagnostics

Sold / distributed

Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.

Why it was recalled

When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.

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 XT3400 Chemistry System, Product code 6844458