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.

Test tube with blood sample for COVID-19 test, novel coronavirus 2019 found in Wuhan, China — • Source: Shutterstock

Abbott Molecular Inc.’s recall of certain COVID-19 tests that are at risk of false positive results falls into the class I high-risk category, the US Food and Drug Administration said on 14 October.

The FDA had initially announced the recall of Abbott Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP diagnostics on...