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UPDATE: Risk of False Positive Lead Test Results with Certain Capillary Blood Collection Tubes Used with Magellan Diagnostics LeadCare Testing Systems – FDA Safety Communication
On May 9, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Kabe Labortechnik GmbH after an Agency inspection revealed significant Quality System Regulation and Medical Device Reporting violations. This firm is a manufacturer of blood collection tubes, including the SAFE-T-FILL Capillary Blood Collection Systems distributed by ASP Global and referenced in the FDA’s Safety Communication, Risk of False Positive Lead Test Results with Certain Capillary Blood Collection Tubes Used with Magellan Diagnostics LeadCare Testing Systems, issued April 25.
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