UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
FDA Device Recall #Z-2572-2025 - Class II, August 13, 2025
Recall Summary
| Recall Number | Z-2572-2025 |
| Classification | Class II - Moderate risk |
| Date Initiated | August 13, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Beckman Coulter Inc. |
| Location | Brea, CA |
| Product Type | Devices |
| Quantity | N/A |
Product Description
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
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.
Distribution Pattern
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.
Lot / Code Information
UDI: 15099590701574/ Serial Numbers: BB33238, BB33239, BB42317, BC05150, BC08198, BC10226, BC16320, BC21392, BC23453, BC25457, BC25465, BC30527, BC32542, BC42721, BC42726, BC49882, BD13219, BD41570, BD46639, BD46643, BD46646, BE01022, BE02044, BE02052, BE04080, BE21222, BE24254, BE24257, BE29334, BE31336, BE33366, BE42455, BE42459, BE46517, BE49539, BE49541, BF10071, BF12126, BF12129, BF18194, BF33377, BF40462, BG04041, BG04042, BG04053, BG05080, BG11182, BG11184, BG11185, BG14195, BG14200, BG14204, BG14208, BG16220, BG16231, BG17238, BG17250, BG17260, BG19283, BG20292, BG20294, BG25395, BG25412, BG25413, BG26435, BG40563, BG45631, BG46635, BH04028, BH04029, BH05051, BH19220, BH24260, BH31328, BD46642, BG22347, BG20307, BD46640, BC32545
Other Recalls from Beckman Coulter Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2974-2026 | Class II | Beckman Coulter DxC 500 AU Clinical Analyzer Mo... | Jul 15, 2026 |
| Z-2973-2026 | Class II | Beckman Coulter DxC 500i Clinical Analyzer Modu... | Jul 15, 2026 |
| Z-2888-2026 | Class II | REF # D23352, MicroScan LabPro V5.03 Panel Upda... | Jun 26, 2026 |
| Z-2889-2026 | Class II | REF # D23354, MicroScan LabPro V5.03 Panel Upda... | Jun 26, 2026 |
| Z-0541-2026 | Class II | DxFLEX Flow Cytometer Catalog Number C78500 UD... | Sep 22, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.