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Recall Observatory FDA recall evidence

Device 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.

Z-1321-2018

January 24, 2018

Class II

Product summary

Firm
Mindray DS USA, Inc. dba Mindray North America
Event
Event 79556
Status
Terminated
Classification
Class II
Quantity
496
Official record key
device-enforcement:Z-1321-2018

Official wording

Reason: 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.

Code information: Lot Numbers: 2017060105 ¿ 2017041106 ¿ 2017010701 ¿ 2016121401 ¿ 2016112301 ¿ 2016111302

Distribution pattern: US Distribution including Puerto Rico and to the states of : CA, MI, NC, TX, and WA. .

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.