FDAJanuary 24, 2018device
Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L container) The M-53D diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray BC-5390 Hematology Analyzer.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzer may cause the system to produce an elevated platelet background count.
What to do
FDA enforcement status: Terminated
Brands named
mindray ds usa inc dba mindray north americamindraymindray ds
UPCs
10500786700
Recall history
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