Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Apo B Reagent Recalled by Beckman Coulter Ireland, Inc. Due to The product Value Assignment Sheet (VAS) is used...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Beckman Coulter Ireland, Inc. directly.
Affected Products
Apo B Reagent, REF: OSR6143
Quantity: 2747 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Beckman Coulter Ireland, Inc.
Beckman Coulter Ireland, Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report