FDA-Device2025-06-04Class III
Apo B Reagent, REF: OSR6143
Beckman Coulter Ireland, Inc.
Hazard
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.
Sold states
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.
Affected count
2747 units
Manufactured in
Lismeehan, N/A, O'Callaghan'S Mills, N/A, Ireland
Products
Apo B Reagent, REF: OSR6143
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1815-2025Don't want to check this manually?
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