Mindray Hematology Diluent Recall for Elevated Platelet Background Counts
Mindray is recalling specific lots of M-53D and M-30D hematology diluents because they may cause the analyzer to produce an elevated platelet background count.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a potential diagnostic error (elevated platelet background count) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Mindray DS USA, Inc. is recalling certain lots of M-53D diluent used with the BC-5390 Hematology Analyzer and M-30D diluent used with the BC-3200 and BC-3600 Hematology Analyzers. The recall is due to a potential defect where the diluent may cause the system to produce an elevated platelet background count.
The affected M-53D diluent is an azide-free, filtered isotonic solution used for counting and sizing blood cells. The recall covers 496 units of the 20L container (Part Number: 105-007867-00). The affected lot numbers for the M-53D diluent are 2017060105, 2017041106, 2017010701, 2016121401, 2016112301, and 2016111302.
The product was distributed in the United States, including Puerto Rico, and to the states of California, Michigan, North Carolina, Texas, and Washington. Users of the affected analyzers should stop using the recalled diluent and contact Mindray for instructions on how to return the product or obtain a replacement.
The recalled product
- 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
- Mindray DS USA, Inc. dba Mindray North America
- Hazard
- Affected units
- 496
Distribution
Part of a larger recall action
This product is one of 2 recalled by Mindray DS USA, Inc. dba Mindray North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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