Beckman Coulter recalls specific lots of COULTER DxH Diluent (REF 628017) used for blood cell counting. Diluent with incorrect conductivity, osmolality, or pH may cause inaccurate blood test results. Affected lots begin with 3541, 3542, 3543, or 3544.
Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.
Beckman Coulter is recalling specific lots of COULTER DxH Diluent (used for blood cell counting) because some batches had incorrect chemical levels. Using these faulty diluents could lead to inaccurate blood test results, which might affect medical diagnoses.
The diluent had conductivity, osmolality, or pH levels outside the intended manufacturing specifications. This could cause blood cell counts and sizes to be inaccurate, potentially leading to incorrect medical diagnoses if used in blood tests.
Users of blood cell counting equipment who have the recalled diluent lots (beginning with 3541, 3542, 3543, or 3544) are affected. Laboratory staff and medical professionals using these specific lots are most at risk of inaccurate test results.
Check the container for lot numbers beginning with 3541, 3542, 3543, or 3544. The product is labeled as COULTER DxH Diluent, REF 628017, used for counting and sizing blood cells.
Look for lot numbers starting with 3541, 3542, 3543, or 3544 on the container.
It is used for counting and sizing blood cells in laboratory testing.
Lot numbers beginning with 3541, 3542, 3543, or 3544 (e.g., 3541500, 3542010, 3543000, 3544010).
No action is required for the diluent if it is not one of the affected lot numbers. Only affected lots need to be checked.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2138-2023 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2138-2023 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
