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.
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Ellume recalled 2,212,335 of the home tests because there’s a chance they can give false-positive results.
The recall is related to the software’s mixing parameters, which may cause false positives if test samples contaminate each other.
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.