FDA-Device2018-04-18Class II
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.
Mindray DS USA, Inc. dba Mindray North America
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.
Sold states
US Distribution including Puerto Rico and to the states of : CA, MI, NC, TX, and WA. .
Affected count
496
Manufactured in
800 Macarthur Blvd, Mahwah, NJ, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1321-2018Don't want to check this manually?
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