Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.
Reason for recall: Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore. Quantity: 2819 Lot/code info: UDI-DI 848838018817 lots 321046, 329835, 330316, 327069, 330317, 336325, 338314, 341161, 303851, 311723
848838018817
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.