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# Warning Letter Issued to Meridian Bioscience
- URL: https://www.fdaweb.com/warning-letter-issued-to-meridian-bioscience/
- Published: 2026-01-27T12:00:00.000Z
- Updated: 2026-09-14T15:31:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160552

FDA has issued a [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/meridian-bioscience-inc-720826-12222025?ref=fdaweb.com) to Meridian Bioscience over serious quality system violations involving blood lead testing devices manufactured by its subsidiary, Magellan Diagnostics, underscoring an ongoing regulatory focus on the company’s LeadCare products. The 12/22 warning follows an FDA inspection conducted this past summer at Magellan’s Massachusetts facility. The agency found multiple lapses in quality controls, device design validation, complaint handling, and required safety reporting that render the company’s LeadCare blood lead testing systems “adulterated” under federal law. The letter warns that failure to act could lead to enforcement actions, including seizures or fines.

The Warning Letter is the latest chapter in a regulatory history stretching back more than a decade involving LeadCare devices — point-of-care tests widely used to screen for elevated blood lead levels. In 2017, FDA issued a public safety advisory cautioning laboratories and healthcare providers not to use LeadCare testing systems with venous (arm-drawn) blood samples after studies showed these devices could under-report actual lead levels when certain blood collection tubes were used.

In mid-2021, Magellan initiated a Class 1 recall of LeadCare II, LeadCare Plus, and LeadCare Ultra test kits because they could underestimate blood lead levels, posing a risk of serious injury if used to monitor patients. Healthcare providers were advised to discontinue use of affected lots and quarantine remaining inventory.

Federal prosecutors have also taken action. In 2023, Magellan and its parent agreed to plead guilty and pay $42 million to resolve charges that the company misled customers and FDA about a serious malfunction that produced falsely low blood lead results when LeadCare devices were used with venous samples.