FDA Clarifies Software Link In Abbott COVID-19 Lab Test Recall
The recall is related to the software’s mixing parameters, which may cause false positives if test samples contaminate each other.
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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.
Abbott says DexCom’s patent suits involve technology that was already the subject of a settlement, and raise venue questions.
In this week’s podcast, EU regulatory editor Amanda Maxwell brings listeners up to speed on the latest news from the European Union, including recent module updates and compliance expectations for the Eudamed database.