Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hematology Diluent M-53D used with BC-5390 Hematology Analyzer Recalled by Mindray DS USA, Inc. dba Mindray North America Due to Certain lots of M-30D diluent used with BC-3200...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mindray DS USA, Inc. dba Mindray North America directly.
Affected 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.
Quantity: 496
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 5 states: CA, MI, NC, TX, WA
About Mindray DS USA, Inc. dba Mindray North America
Mindray DS USA, Inc. dba Mindray North America has 39 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report