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 COULTER DxH Diluent is used as an isotonic buffered diluent for counting and sizing blood cells in clinical laboratories. Healthcare providers typically use this product in conjunction with blood analyzers to ensure accurate blood testing results.
The specific lots of diluents in question have been found to contribute to elevated platelet background counts, which can distort test results and lead to false readings.
This recall is not part of a broader industry pattern.
Patients relying on accurate blood cell analysis may face misdiagnosis, which can affect treatment decisions. Immediate cessation of use is crucial to prevent potential health risks.
Look for the catalog numbers and lot numbers on the product label or packaging to verify if your diluent is affected by the recall.
Expect a timeline of 4-8 weeks for processing refunds or replacements after contacting Beckman Coulter.
Keep records of your purchase, including receipts and any communication with Beckman Coulter regarding the recall.
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.
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