Summary
The FDA issued a Class III for Apo B Reagent, REF: OSR6143 by Beckman Coulter Ireland, Inc.. Reason: 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 g.
Details
Source
Device Recall
External ID
Z-1815-2025
Action Date
2025-06-04
Status
Ongoing
Category
device
Product Description
Apo B Reagent, REF: OSR6143
Lot/Code Info: Lot # 2631/UDI: 15099590010409
Quantity Affected: 2747 units
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-23
Company
O'Callaghan'S Mills, N/A
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 185 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beckman Coulter Ireland, Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beckman Coulter Ireland, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beckman Coulter Ireland, Inc. have FDA actions?
Beckman Coulter Ireland, Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1815-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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