Device product
VITROS XT3400 Chemistry System, Product code 6844458
Z-2878-2020
Product summary
- Event
- Event 86096
- Status
- Terminated
- Classification
- Class II
- Quantity
- pending
- Official record key
device-enforcement:Z-2878-2020
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 J34500122 J34500231
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
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.