Beckman Coulter recalled the UniCel DxH 900 COULTER Cellular Analysis System on August 13, 2025, due to erroneous high hemoglobin results. The devices may misreport hemoglobin levels on samples with elevated white blood cell counts. This recall affects devices distributed worldwide, including the U.S.
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Beckman Coulter Inc. or your healthcare provider for instructions. Notification method: E-Mail
The recall involves the UniCel DxH 900 COULTER Cellular Analysis System configured with the Led HGB Photometer, REF: C11478. The device was sold worldwide, including all U.S. states. Specific models affected include serial numbers BB33238, BB33239, and others.
The hematology analyzers can produce erroneously high hemoglobin results, leading to potential misdiagnosis and inappropriate treatment. This issue arises specifically with samples that have high white blood cell counts.
No specific incidents were reported in the recall notice. However, the potential for misdiagnosis raises significant health risks.
Stop using the device immediately. Follow the manufacturer's recall instructions and contact Beckman Coulter Inc. or your healthcare provider for guidance.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2572-2025.
Abiomed issued a recall for 10,153 Automated Impella Controllers on October 1, 2025. The devices face potential cybersecurity vulnerabilities related to their operating system. Healthcare providers and patients should stop using these devices immediately.
Acuity Specialty Products recalled its Wyandotte Sanifect E3 hand sanitizer on September 29, 2025. The recall affects multiple package configurations due to potential methanol contamination. Consumers should stop using the product immediately and contact the company for guidance.
AFCO recalled hand sanitizer on September 29, 2025, due to a risk of methanol contamination. The company failed to conduct required testing on incoming alcohol components. Consumers should stop using the product immediately.