Beckman Coulter Ireland, Inc. is recalling 2,747 units of its Apo B Reagent (REF: OSR6143) used in diagnostic laboratories. An error in the Value Assignment Sheet (VAS) used to calibrate the device can cause patient test results for apolipoprotein B to be incorrectly high, potentially exceeding the allowable error limit by up to 42%. Because this is a laboratory product, professionals should stop using the affected lot immediately and contact the manufacturer or their distributor for a replacement.
The incorrect calibration values can lead to patient test results with a positive bias of up to 42%. While the manufacturer considers the health risk to be negligible or limited, erroneous test results could lead to the misinterpretation of a patient's health status.
Recall #: Z-1815-2025; Quantity: 2747 units
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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