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.
Rather than asking customers to return affected tests, the FDA’s update notes the automated software required to process tests is being corrected. Currently 187 software installations responsible for analyzing the results of over 10 million tests are in the process of being corrected.