--- title: "COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood c... — FDA record Z-2138-2023 | Is It on Recall" description: "Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications." url: https://isitonrecall.com/recall/fda-device-z-2138-2023-coulter-dxh-diluent-ref-628017-diluent-used-for-counting-and-sizing-blood-cells/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells — FDA record Z-2138-2023 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date May 31, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells - **Reason**: Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications. - **Classification**: Class II - **Recalling firm**: Beckman Coulter, Inc. - **Quantity**: 335, 448 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-2138-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2138-2023%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | UDI DI 150995901HEMDILUENT5R; Container Number: 0001-0401: Lot numbers: Lot Numbers Beginning with 3541: 3541500, 3541510, 3541520, 3541550, 3541610, 3541620, 3541670, 3541690, 3541750, 3541770, 3541790, 3541810, 3541830, 3541860, 3541880, 3541900, 3541910, 3541920, 3541930, 3541940, 3541950, 3541990; Lot Numbers Beginning with 3542: 3542010, 3542030, 3542050, 3542070, 3542110, 3542150, 3542170, 3542180, 3542190, 3542230, 3542250, 3542260, 3542270, 3542310, 3542350, 3542370, 3542450, 3542490, 3542510, 3542530, 3542570, 3542590, 3542610, 3542630, 3542650, 3542670, 3542720, 3542740, 3542760, 3542780, 3542800, 3542820, 3542840, 3542850, 3542900, 3542920, 3542940, 3542960, 3542980; Lot Numbers Beginning with 3543: 3543000, 3543020, 3543040, 3543050, 3543080, 3543120, 3543140, 3543160, 3543170, 3543180, 3543200, 3543220, 3543240, 3543280, 3543300, 3543320, 3543340, 3543360, 3543370, 3543390, 3543410, 3543430, 3543460, 3543480, 3543500, 3543540, 3543560, 3543580, 3543610, 3543850, 3543870, 3543890, 3543910, 3543930, 3543950, 3543970, 3543990; Lot Numbers Beginning with 3544: 3544010, 3544030, 3544040, 3544050, 3544070, 3544090, 3544110, 3544130, 3544150, 3544160, 3544170, 3544190, 3544210, 3544230, 3544250 | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide distribution - US Nationwide and the countries of Argentina, Bolivia (Plurinational State of), Brazil, Canada, Chile, Colombia, Ecuador, Hong Kong, Indonesia, Kuwait, Mexico, Panama, Peru, Puerto Rico, Taiwan, Trinidad and Tobago, Uruguay, and Viet Nam. States below are derived from the distribution text, including nationwide wording. 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These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2138-2023%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Beckman Coulter Inc. records](https://isitonrecall.com/brand/beckman-coulter-inc/)