FDA-Device2018-07-11Class II
VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
Ortho-Clinical Diagnostics
Hazard
There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control samples and patient samples.
Sold states
Worldwide distribution. US nationwide, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, and Sweden
Affected count
5712
Manufactured in
100 Indigo Creek Dr, Rochester, NY, United States
Products
VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2344-2018Don't want to check this manually?
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