Ortho-Clinical Diagnostics recalls VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445) Product Usage: For use in t

Recalled July 10, 2013 · FDA recall Z-1648-2013 · Ortho-Clinical Diagnostics

Hazard

There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt. · FDA Class II

Units

Total 69 units (28 units domestically and 41 units internationally)

Sold at

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

Description

There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.

Product

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.)

Manufacturer(s)

Ortho-Clinical Diagnostics

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