FDA-Device2019-08-14Class II
VITROS 250 Chemistry System, clinical chemistry analyzer
Ortho Clinical Diagnostics
Hazard
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Sold states
Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
Affected count
2
Manufactured in
100 Indigo Creek Dr, N/A, Rochester, NY, United States
Products
VITROS 250 Chemistry System, clinical chemistry analyzer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2175-2019Don't want to check this manually?
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