The Binding Site—Freelite Human Kappa Free Kits: High and Low Quality Controls May Exhibit Positive Bias

June 2, 2021 | Strategic Insights for Health System


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Problem:In a May 19, 2021, Urgent Medical Device Correction letter submitted by an ECRI member hospital, The Binding Site (TBS) states that the high and low quality controls (QC) of the above kits may exhibit an approximately 10% positive bias compared to their assigned values. Users may experience QCs consistently reporting results close to their upper limits, and QC failures may occur. TBS also states that sample results are not affected, only QC results. When valid QC results are obtained in line with the product labeling, the affected kits may continue to be used to report patient results. The manufacturer has not confirmed the...

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