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.
FDA Recall Z-1321-2018 · Posted None
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Recalling FirmMindray DS USA, Inc. dba Mindray North America
Recall StatusTerminated
Product CodeGIF
Date Initiated2018-01-24
Date Terminated2019-04-19
Product Quantity496
Reason for Recall
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.
Firm Action
Letters dated January 24, 2018, were sent to consignees with the following instructions: The issue manifests intermittently, therefore, you may continue to use affected lots if the background check is successfully completed. Discard affected lots which cause the system to display the error message background abnormal. Mindray will replace the potentially affected lots at no cost. Please contact Technical Support to order replacement product. For further questions, please call (201) 995-8407.
Root Cause
Material/Component Contamination
Distribution Pattern
US Distribution including Puerto Rico and to the states of : CA, MI, NC, TX, and WA. .
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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