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Ortho-Clinical Diagnostics recalls VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and d
Recalled June 17, 2015 · FDA recall Z-1743-2015 · 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. · FDA Class II
Units
1895 units total (907 domestically & 988 internationally)
Sold at
Worldwide Distribution-US (nationwide), Brazil, Chile, Mexico, Australia, Hong Kong, India, Taiwan, Belgium, Denmark, France, Ireland, Italy, Portugal, Romania, Spain, Sweden and the UK.
Description
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.
Product
VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
Manufacturer(s)
Ortho-Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →