Ortho-Clinical Diagnostics recalls VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 -…

Recall date

April 1, 2020

Source

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

Recall number

Z-1931-2020

FDA classification

Class II

Brand / firm

Ortho-Clinical Diagnostics

Sold / distributed

US Nationwide distribution.

Why it was recalled

The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in 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 Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction.