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Ortho Clinical Diagnostics recalls VITROS XT3400 Chemistry System, Product code 6844458
Recalled September 2, 2020 · FDA recall Z-2878-2020 · Ortho Clinical Diagnostics
Hazard
When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results. · FDA Class II
Units
pending
Sold at
Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
Description
When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.
Product
VITROS XT3400 Chemistry System, Product code 6844458
Manufacturer(s)
Ortho Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →