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Ortho Clinical Diagnostics recalls VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
Recalled August 14, 2019 · FDA recall Z-2184-2019 · Ortho Clinical Diagnostics
Hazard
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System · FDA Class II
Units
55
Sold at
Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
Description
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Product
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
Manufacturer(s)
Ortho Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →