FDA-Device2023-09-27Class II
VITROS XT Chemistry Products TBIL-ALKP Slides
Ortho-Clinical Diagnostics, INc.
Hazard
Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.
Sold states
Worldwide Distribution: US (nationwide) and OUS (foreign) distribution to countries of: Bermuda, Belgium, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, Italy, India, Japan, Mexico, Netherlands, Norway, Singapore, Spain, Sweden, Portugal, Russia, United Kingdom
Affected count
52,456 units
Manufactured in
513 Technology Blvd, Rochester, NY, United States
Products
VITROS XT Chemistry Products TBIL-ALKP Slides
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2623-2023Don't want to check this manually?
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