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# FDA Warning Letter to Magellan Diagnostics
- URL: https://www.fdaweb.com/fda-warning-letter-to-magellan-diagnostics/
- Published: 2017-10-23T12:00:00.000Z
- Updated: 2026-09-14T22:57:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139938

FDA has issued a [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm581591.htm?ref=fdaweb.com) to Magellan Diagnostics for modifying versions of two of its blood lead testing systems without the agency’s required clearance or approval and for failing to submit medical device reports after becoming aware of customer complaints involving discrepancies in blood lead test results. The letter is the latest chapter in FDA’s investigation of the company and its testing systems due to concerns that they may underestimate blood lead levels and give inaccurate results when processing venous blood samples ([see earlier story](https://www.fdaweb.com/magellan-recalls-leadcare-test-systems/)). In June, Magellan recalled all lots of the tests manufactured between 9/2013 and the present and distributed between 1/1/14 and 5/22/17.

“The FDA has serious concerns about Magellan Diagnostics’ actions after learning about inaccuracies in results using its blood lead testing devices – tests that the American people depend on,” CDRH Office of In Vitro Diagnostics and Radiological Health **Donald St. Pierre** is quoted in a [release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm581683.htm?ref=fdaweb.com) as saying. “The evidence uncovered during the inspection shows that the company put patients at risk after it recognized that its tests could provide inaccurate results and failed to take appropriate steps to report this issue and work through a strategy to effectively mitigate problems with the FDA. We take the violations described in the Warning Letter very seriously and are continuing to work with the company to investigate the root cause of the falsely low test results.”