Abbott Molecular Inc.
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The test, which is the first for the condition to win an EUA using actual patient samples, provides results in about three and a half hours.
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.
With news of high-risk medical device recalls and troubles with COVID-19 diagnostics, product safety was of paramount concern to Medtech Insight readers in September. Also topping the most-read list were articles focused on pediatric patients, the revocation of emergency use authorizations for products to treat and diagnose COVID-19, and more.
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In Vitro Diagnostics
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