FDA-Device2019-11-13Class II
VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form.
Ortho-Clinical Diagnostics
Hazard
Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
Sold states
Domestic distribution nationwide. Foreign distribution to Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, the Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, and United Kingdom.
Affected count
1365545 total
Manufactured in
513 Technology Blvd, N/A, Rochester, NY, United States
Products
VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0269-2020Don't want to check this manually?
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