FDA issues highest recall for certain radioimmunoassay products, glucose meters
The Food and Drug Administration has identified Class I recalls of two products: certain platelet factor 4 radioimmunoassay products by Instrumentation Laboratories due to customer reports of obtaining an invalid calibration curve; and certain StatStrip Glucose Hospital Meters by Nova Biomedical due to a scanning issue that could lead to a glucose result being assigned to the wrong patient’s medical record or quality control ID. Nova Biomedical reported one serious injury related to the issue as of Oct. 5. The FDA said no deaths have been associated with either issue.
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