FDA-Device2014-07-09Class II
syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
Siemens Healthcare Diagnostics, Inc.
Hazard
Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review.
Sold states
Worldwide Distribution. US Nationwide, Canada, Australia, Belgium, Czech Republic, Germany, Denmark, Finland, France, United Kingdom, Italy, Netherlands, Portugal, Slovakia, Singapore, Japan, and Spain.
Affected count
336
Manufactured in
500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, United States
Products
syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1944-2014Don't want to check this manually?
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