Beckman Coulter Ireland, Inc. recalls Apo B Reagent, REF: OSR6143

Recall date

April 23, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1815-2025

FDA classification

Class III

Brand / firm

Beckman Coulter Ireland, Inc.

Sold / distributed

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…

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Apo B Reagent, REF: OSR6143