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# FDA Hits Block Scientific Over Covid Products
- URL: https://www.fdaweb.com/fda-hits-block-scientific-over-covid-products/
- Published: 2021-04-19T12:00:00.000Z
- Updated: 2026-09-14T16:55:21.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149137

FDA has sent Block Scientific a [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/block-scientific-609533-03182021?ref=fdaweb.com) after reviewing the firm’s Web site ([www.blockscientificstore.com](http://www.blockscientificstore.com/?ref=fdaweb.com)) and determining it is marketing Covid-19 test kits without agency approval, clearance, or authorization. FDA also said the products are misbranded because Block failed to notify the agency of its intent to introduce the devices into commercial distribution. The letter instructs the company to take immediate action to address the cited violations.