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Mindray DS USA, Inc. dba Mindray North America recalls Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L container) The M-53D
Recalled April 18, 2018 · FDA recall Z-1321-2018 · Mindray DS USA, Inc.
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. · FDA Class II
Units
496
Sold at
US Distribution including Puerto Rico and to the states of : CA, MI, NC, TX, and WA. .
Description
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.
Product
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.
Manufacturer(s)
Mindray DS USA, Inc. dba Mindray North America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →