Beckman Coulter recalled 76,098 units of COULTER DxH Diluent on November 10, 2025. The recall affects specific lots contributing to elevated platelet background counts in analyzers. Healthcare providers and patients must stop using this product immediately.
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Beckman Coulter, Inc. or your healthcare provider for instructions. Notification method: Letter
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The recalled products include COULTER DxH Diluent, REF 628017 and COULTER DxH ECO Diluent, REF C67250. These diluents were distributed worldwide, including states such as California, Texas, and New York, and countries like Canada, Argentina, and Vietnam.
Specific lots of the diluents may cause elevated platelet Daily Checks background counts during use with analyzers. This can lead to inaccurate blood cell counting and potential misdiagnosis.
As of the recall date, there are no reported injuries or deaths associated with the use of these diluents. However, the potential for misdiagnosis poses a significant risk to patient safety.
Patients and healthcare providers should stop using the diluents immediately. They must follow the recall instructions provided by Beckman Coulter and contact their healthcare provider for further guidance.
For more information, contact Beckman Coulter, Inc. at their customer service number or visit their website for recall details.
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