Home / Recalls / Beckman Coulter Ireland, Inc. / Z-1815-2025

Z-1815-2025 Class III Ongoing

Recalled by Beckman Coulter Ireland, Inc. — O'Callaghan'S Mills, N/A

FDA device recall Z-1815-2025 was initiated by Beckman Coulter Ireland, Inc. on April 23, 2025 and is designated Class III. 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 co… The recall status is ongoing. Affected quantity: 2747 units.

Recall Details

Product Type: Devices
Report Date: June 4, 2025
Initiation Date: April 23, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2747 units

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.

Distribution Pattern

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