Medical device recalls Moderate risk

Ortho-Clinical Diagnostics recalls VITROS Sodium Slides, Catalog # 837 9034

Recall date
May 5, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3280-2018
FDA classification
Class II
Brand / firm
Ortho-Clinical Diagnostics
Sold / distributed
US Nationwide, Bermuda, Austria, Brazil, Canada, Colombia, China, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium and the Netherlands

Why it was recalled

Potential for positively biased 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 Sodium Slides, Catalog # 837 9034

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