Device Recall VITROS 4600 Chemistry System

Software Version 3.1 & Below; Serial Numbers J46000108 - J46000492 (the serial numbers are sequential; J Numbers are analogous to serial numbers)

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution-US (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), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics. || 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).

Software Version 3.2 and below; Serial Numbers J46001001 -J4600636

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - US Nationwide and the countries of Puerto Rico, and foreign distribution to: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Israel, Italy, Japan, Kenya, Mexico, Panama, Philippines, Poland, Romania, Russia, Singapore, Spain, Taiwan, Turkey, and Venezuela.

VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below; IVD. || Product Usage: || 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.)

Software Version 3.2 and below; Serial Numbers J46000001 - 46000678

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - US 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, Catalog Number 6802445, Unique Device Identifier Number 10758750012343; IVD. || Product Usage: || For in vitro diagnostic use. 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.)

Version 2.0 & Below

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Brazil, Canada, Chile, Argentina, Paraquay, Ecuador, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, UK, Northern Europe, France, Germany, Italy, Spain and Portugal.

VITROS 4600 Chemistry System Software || For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.

Serial numbers: J46000021, J46000110 through J46000177

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - USA Nationwide including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI & WV, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, PR, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain

VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445) || Product Usage: 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.)