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Ortho-Clinical Diagnostics, INc. recalls VITROS XT Chemistry Products ALKP Slides
Recalled September 27, 2023 · FDA recall Z-2624-2023 · Ortho-Clinical Diagnostics
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. · FDA Class II
Units
402,966 units
Sold at
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
Description
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.
Product
VITROS XT Chemistry Products ALKP Slides
Manufacturer(s)
Ortho-Clinical Diagnostics, INc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →