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Ortho-Clinical Diagnostics recalls VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
Recalled July 11, 2018 · FDA recall Z-2344-2018 · 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. · FDA Class II
Units
5712
Sold at
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
Description
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.
Product
VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
Manufacturer(s)
Ortho-Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →