Apo B Reagent, REF: OSR6143
FDA Recall #Z-1815-2025 — Class III — April 23, 2025
Product Description
Apo B Reagent, REF: OSR6143
Reason for Recall
The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.
Recalling Firm
Beckman Coulter Ireland, Inc. — O'Callaghan'S Mills, N/A
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
2747 units
Distribution
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, MD, MI, NJ, NY, OH, OK, OR, PA, TX, VA, WA, WV and the countries of Argentina, Australia, Belarus, Belgium, Bulgaria, Canada, China, Czechia, Egypt, Estonia, France, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Korea, Republic of, Malaysia, Netherlands, New Zealand, Russian Federation, Saudi Arabia, Slovakia, Spain, Switzerland, Taiwan, Province of China, United Kingdom of Great Britain and Northern Ireland, United States of America, Viet Nam.
Code Information
Lot # 2631/UDI: 15099590010409
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated