Becton, Dickinson and Company (BD Bio Sciences) has recalled 130 units of the BD FACSDuet and BD FACSDuet Premium Sample Preparation Systems used with software version 1.4.1. A software error can cause the system to dispense uneven amounts of patient specimens into testing tubes, specifically resulting in tube volumes that are at least 3% higher in the first tube compared to the second. This defect can lead to inaccurate lab results, such as absolute cell counts being 20% higher than they should be, which may require patients to undergo additional blood collection or experience delays in their therapy.
The software malfunction causes incorrect volume dispensing during the sample preparation process, leading to falsely elevated lab results. These inaccuracies can result in incorrect medical diagnoses, unnecessary follow-up procedures like repeat blood draws, and potentially delayed or inappropriate patient treatment.
Manufacturer correction/instruction
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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