Ortho-Clinical Diagnostics recalls VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 10758750001330) Product Usage: Performs discrete…

Recall date

April 8, 2019

Source

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

Recall number

Z-1935-2019

FDA classification

Class II

Brand / firm

Ortho-Clinical Diagnostics

Sold / distributed

US Nationwide Distribution

Why it was recalled

Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.

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 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 10758750001330) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.