Ortho Clinical Diagnostics Inc recalls Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic S…

Recall date

November 29, 2018

Source

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

Recall number

Z-0844-2019

FDA classification

Class II

Brand / firm

Ortho Clinical Diagnostics Inc

Sold / distributed

Distributed nationwide domestically. Foreign distribution to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, and the Netherlands.

Why it was recalled

A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.

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 Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma