Z-2138-2023Class II

COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells

Name: Z-2138-2023 COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
Creator: Beckman Coulter, Inc.
Published: 2023-05-31
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2023-05-31 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter, Inc. began a recall of COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells on 2023-05-31. FDA classified it as Class II and gives the reason as "Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2138-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-31
Posted: 2023-07-12
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
Product code: GIF Diluent, Blood Cell
Reason for recall: Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice on 05/31/2023 by email and mail. The notice explained the issue, its impact on the patient, and requested the following actions be taken: "Inspect the lot number set up on your instrument(s) and your current inventory with the corresponding container number (see Appendix A). Locate the container number on your diluent reagent 2D or Linear barcode label (see Appendix B). Contact Beckman Coulter Customer Technical Support Organization to replace the affected containers in your current inventory. Consult with your laboratory management to determine whether a retrospective review of results is necessary.
Quantity in commerce: 335, 448 units
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2138-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2138-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-12

Product code GIF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)