US FDA Tells Providers To Stop Using Eco-Med Ultrasound Gels Due To Contamination Risk
The agency is asking health care providers to dispose of all ultrasound gels and lotions from the defunct Canadian manufacturer after learning that manufacturing problems may have brought on bacterial contamination.
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Now-defunct Canadian manufacturer Eco-Med Pharmaceutical Inc. initiated the recall of its gels and lotions – sold under an array of product names – because there’s a chance they could be contaminated with harmful bacteria.
The recall is related to potential false positives that may occur if a genuine positive test sample overflows into an adjacent sample that would have otherwise tested negative.
The agency asked consultants Booz Allen Hamilton to evaluate its handling of diagnostic EUAs as a way to prepare for potential future pandemics.