Z-2574-2025 Class II Ongoing
FDA device recall Z-2574-2025 was initiated by Beckman Coulter Inc. on August 13, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- September 24, 2025
- Initiation Date
- August 13, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Reason for Recall
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.