DOJ Memo Could Offer Additional Defenses In Enforcement Actions
Industry should be cautious in interpreting a recent US Department of Justice memo stating DOJ wouldn’t take enforcement actions based on failure to comply with guidance documents alone, according to experts. But the document still could offer assistance to manufacturers fighting enforcement actions.
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The US Department of Justice has ordered its attorneys to ask for the dismissal of more whistleblower cases, and to avoid basing civil enforcement actions solely on guidance documents. Both could lead to fewer enforcement actions against device manufacturers.
The recall is related to the software’s mixing parameters, which may cause false positives if test samples contaminate each other.
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.