Global Self-Testing Market: Restraint
The increasing number of product recalls of self-testing kits by regulatory authorities such as the U. S. FDA, is expected to hinder the global self-testing market growth over the forecast period. For instance, in November 2021, the U.S. Food and Drug Administration (FDA) issued a recall of approximately 2 million at-home COVID-19 test kits manufactured by the Australian-based biotech company Ellume. Due to a manufacturing flaw, the test kits may produce 'false positives', according to the federal regulatory agency. In October 2021, the company notified the FDA about the defect in some lots. The FDA classified the Ellume test recall as 'the most serious type', known as a Class I recall.
Self-Testing Market Report Snapshots
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