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Siemens Healthcare Diagnostics, Inc. recalls syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
Recalled July 9, 2014 · FDA recall Z-1944-2014 · Siemens Healthcare Diagnostics
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. · FDA Class II
Units
336
Sold at
Worldwide Distribution. US Nationwide, Canada, Australia, Belgium, Czech Republic, Germany, Denmark, Finland, France, United Kingdom, Italy, Netherlands, Portugal, Slovakia, Singapore, Japan, and Spain.
Description
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.
Product
syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →