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Ortho-Clinical Diagnostics recalls VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in v
Recalled May 29, 2019 · FDA recall Z-1364-2019 · Ortho-Clinical Diagnostics
Hazard
Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported · FDA Class II
Units
85 units: US=19;OUS=66
Sold at
Worldwide Distribution - US Nationwide in the states of AZ, CA, IL, OH, FL, TX, MI Foreign: Australia, Belgium, Chile, India, Italy, Japan, South Korea, Spain, Canada,, Phillippines
Description
Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported
Product
VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest
Manufacturer(s)
Ortho-Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →