The FDA issued a class 2 device recall for the Visibly Online Refraction Test because “the firm has not received authorization from FDA to market the product,” the agency stated.
The test is distributed worldwide, including Arizona, California, Delaware, Florida, Illinois, Missouri, Nevada, New York, Ohio, Pennsylvania, Texas, Washington and Utah, according to the FDA’s announcement, dated Aug. 8.
This activity is supported by an educational grant from Genentech, Inc.
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