Abbott Molecular Inc.
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Latest From Abbott Molecular Inc.
Roche Wins FDA Authorization On High-Volume Monkeypox Test
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.
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.
Abbott COVID-19 Lab Test Recall Deemed High-Risk Class I
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.
US Regulatory Roundup, September 2021: Product Safety, Pediatric Devices, EUAs Revoked, And More
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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