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

Recall date

June 30, 2015

Source

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

Recall number

Z-2544-2015

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 may occur during the installation of an Assay Data Diskette (ADD) using Software Versions 2.2.1 through 2.8. If the user is utilizing User- Configured (Modified) parameters, ALL default settings are restored in the VITROS 5,1 FS Chemistry System from the ADD instead of retaining the user modified parameters.

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, IVD --- Ortho Clinical Diagnostics Inc. The VITROS 5,1 FS Chemistry System with enGEN Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)