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Recall Observatory FDA recall evidence

Device product

VITROS XT7600 Integrated System, Product code 6844461

Z-2879-2020

July 20, 2020

Class II

Product summary

Firm
Ortho Clinical Diagnostics
Event
Event 86096
Status
Terminated
Classification
Class II
Quantity
pending
Official record key
device-enforcement:Z-2879-2020

Official wording

Reason: 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.

Code information: Serial numbers J76000050 - 76000566

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.