Ortho-Clinical Diagnostics recalls VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic

Recall date

September 22, 2017

Source

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

Recall number

Z-0911-2018

FDA classification

Class II

Brand / firm

Ortho-Clinical Diagnostics

Sold / distributed

Worldwide distribution: US Nationwide (including Puerto Rico), Bermuda, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain, Poland, and Russia.

Why it was recalled

This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.

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 DAT Performance Verifier I in vitro diagnostic