Class II — Beckman Coulter Inc.
| Recalling firm | BECKMAN COULTER, INC. |
|---|---|
| Registered facility | View this company's 22 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts. |
| Product | UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478 |
| Quantity | N/A |
| 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, Hung… |
| Initiated | 2025-08-13 |
| Classified | 2025-09-17 |
| Recall number | Z-2572-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Beckman Coulter Inc. (Z-2572-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97464/
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