Beckman Coulter, Inc. is recalling 76,098 units of COULTER DxH Diluent and DxH ECO Diluent because certain batches may cause elevated background platelet counts during daily analyzer checks. This issue involves laboratory analysis systems used to count and size blood cells, and the defect can interfere with the accuracy of diagnostic testing. The recall affects several lots of the isotonic buffered diluents distributed nationwide and internationally.
The affected diluent lots can contribute to high background counts during the system's 'Daily Checks' cycle. This may lead to inaccurate laboratory results or the inability to validate analyzer performance, potentially impacting patient diagnostic decisions.
Used on UniCel DxH Coulter Cellular Analysis Systems and Slidemaker Stainers.
Used in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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