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Ortho Clinical Diagnostics recalls VITROS XT7600 Integrated System, Product code 6844461

Recalled September 2, 2020 · FDA recall Z-2879-2020 · 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 XT7600 Integrated System, Product code 6844461
Manufacturer(s)
Ortho Clinical Diagnostics

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

Ortho Clinical Diagnostics recalls VITROS XT7600 Integrated System, Product code 6844461 | RecallWatchUSA