VITROS 4600 Chemistry System

Software Version 3.0 and below; Serial Numbers J46000012 - J46000456 (serial numbers are sequential; J Numbers are analogous to serial numbers)

Clinical Chemistry and Clinical Toxicology Devices

1

No

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

VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. || The VITROS 4600 Chemistry 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.

VITROS ALT, ALKP, AST, CHE, CK, GGT and LDH results generated on VITROS 4600 Chemistry System, VITROS 5600 Integrated System and VITROS 5,1 FS Chemistry SystemVITROS 4600 Chemistry SystemProduct Code: 6802445Affected Software Versions: 3.0 and lowerVITROS 5600 Integrated SystemProduct Code: 6802413Affected Software Versions: 3.0 and lowerVITROS 5,1 FS Chemistry SystemProduct Codes: 6801375, 6801890Affected Software Versions: 2.7 and lowerMultiple assays affected

VITROS 3600 Immunodiagnostic Systems, VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Systems (Software Versions 3.0 & below) VITROS 3600 Immunodiagnostic System System Product Code: 6802783 VITROS 4600 Chemistry System System Product Code: 6802445 VITROS 5600 Integrated System System Product Code: 6802413