Z-2575-2025Class II

UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858

Name: Z-2575-2025 UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
Creator: Beckman Coulter Inc.
Published: 2025-08-13
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-08-13 / Open, Classified

FDA source

Beckman Coulter Inc. began a recall of UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858 on 2025-08-13. FDA classified it as Class II and gives the reason as "Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2575-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-13
Posted: 2025-09-17
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
Product code: GKZ Counter, Differential Cell
Reason for recall: Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
FDA root cause: Component change control
Action: On August 13, 2025, Beckman Coulter initiated a "Urgent Medical Device Recall" notification via E-Mail. Beckman Coulter expanded the recall to additional consignees September 25, 2025 Beckman Coulter asked consignees to take the following actions: For specimens with a WBC count > 30 x 103 and = 90 x 103 cells/L, follow the actions listed within the customer letter. For specimens with a WBC count > 90 x 103 cells/L, follow the actions listed within the customer letter. To identify WBC counts > 30 x 103 cells/L, consider implementing decision rules within your Laboratory Information System (LIS), Middleware, or on affected instruments. Consult your Medical Director to determine if a retrospective review of results is warranted. Beckman Coulter recommends posting this letter on or near the affected analyzers Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected products listed above to another laboratory, please provide them a copy of this letter. Acknowledge receipt of the notification.
Distribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WV and the countries of Algeria, Argentina, Australia, Bahrain, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Croatia, Czechia, Egypt, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Korea Republic of, Kuwait, Kyrgyzstan, Libya, Lithuania, Mexico, Nepal, Netherlands, New Zealand, North Macedonia, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Switzerland, Taiwan, Province of China, Thailand, Trinidad and Tobago, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, United States of America, Uruguay, Vietnam.
Product codes and lots: UDI: 15099590192242/ Serial Numbers: AV52143, AZ02628, AZ06676, AZ24836, BA07048, BA08667, BA17727, BA31855, BB10648, BB49881, BC24713

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2575-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2572-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-17
Z-2573-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-17
Z-2574-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-17
Z-2575-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-17

Product code GKZ

K120771Class IIUnicel Dxh 800 Coulter Cellular Analysis SystemBeckman Coulter, Inc. / cleared 2013-03-22

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)