FDAFDA · Food and drugs·Recall number Z-2878-2020
VITROS XT3400 Chemistry System, Product code 6844458
Published September 2, 2020 · Recall initiated: July 20, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ortho Clinical Diagnostics
- Distributor
- 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.
- Lot
- Serial numbers J34500122 J34500231
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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