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Abbott Molecular Inc.

www.abbottmolecular.com

Latest From Abbott Molecular Inc.

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.

Recalls Safety

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.

Recalls Safety

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.

United States Regulation

Overflow Issue With Abbott COVID Tests Could Result In False Positives

The mixture in some faulty Abbott PCR tests could cause COVID-19 positive samples to flow into neighboring negative samples, resulting in false-positive results.

Regulation Commercial
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