FDAMay 7, 2018device
cobas m 511 integrated hematology analyzer, Model Number 07261691190 Product Usage: The cobas m 511 integrated hematology analyzer is a quantitative, automated analyzer with cell locating capability. It is intended for in vitro diagnostic use by a skilled operator in the clinical laboratory. The ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Discrepant results have been reported in patients with severe microcytic anemia (e.g.iron deficiency, thalassemia) and the following parameters are affected: RBC (red blood cell count), HGB (hemoglobin concentration), MCH (mean corpuscular hemoglobin), HCT (hematocrit), and MCV (mean corpuscular volume).
What to do
FDA enforcement status: Terminated
Brands named
roche diagnostics hematologyrocheroche diagnostics
UPCs
07261691190
Recall history
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