Early last month, Abbott announced that some of its COVID-19 tests produced false positives. According to a recent FierceBiotech article, the FDA has upgraded the test issue to a Class I recall. The issue stemmed from problematic software employed by processing equipment at the lab. The software automates the mixing of chemicals with samples from patients, but in certain instances excess liquid is added causing overflow into adjacent wells in the processing tray. This contamination can lead to negative samples yielding false-positive results.
Faulty Abbott Labs COVID-19 Tests Lead to Recall
Problematic software caused an issue that could affect 10 million COVID-19 tests that have already been distributed.
Oct 20, 2021
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