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

Recalled September 9, 2015 · FDA recall Z-2544-2015 · Ortho-Clinical Diagnostics

Hazard

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. · FDA Class II

Units

Catalog 6801375: Domestic 919; Foreign 1251; Catalog 6801890: Domestic 63, Foreign 147

Sold at

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.

Description

Product

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.)

Manufacturer(s)

Ortho-Clinical Diagnostics

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →