FDA-Device2015-06-17Class II
VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
Ortho-Clinical Diagnostics
Hazard
Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient results.
Sold states
Worldwide Distribution-US (nationwide), Brazil, Chile, Mexico, Australia, Hong Kong, India, Taiwan, Belgium, Denmark, France, Ireland, Italy, Portugal, Romania, Spain, Sweden and the UK.
Affected count
1895 units total (907 domestically & 988 internationally)
Manufactured in
100 Indigo Creek Dr, N/A, Rochester, NY, United States
Products
VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1743-2015Don't want to check this manually?
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