FDA-Device2022-09-14Class II
VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Ortho-Clinical Diagnostics, Inc.
Hazard
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Brazil, Canada L3R 4G5 , Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.
Affected count
1148 units
Manufactured in
100 Indigo Creek Dr, N/A, Rochester, NY, United States
Products
VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1676-2022Don't want to check this manually?
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