Ortho-Clinical Diagnostics recalls VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and V…

Recall date

September 10, 2015

Source

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

Recall number

Z-0231-2016

FDA classification

Class II

Brand / firm

Ortho-Clinical Diagnostics

Sold / distributed

Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela.

Why it was recalled

Software Anomaly during ADD Installation on VITROS 5,1 FS Chemistry Systems using Software Versions 2.2.1 through 2.8. The user modified parameters would not be saved as expected, but remained changed to the default values obtained from the ADD disk.

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 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644. Intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest.