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# Warning Letter Issued to Becton Dickinson
- URL: https://www.fdaweb.com/warning-letter-issued-to-becton-dickinson/
- Published: 2018-01-11T12:00:00.000Z
- Updated: 2026-09-14T23:12:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140479

FDA has issued Becton Dickinson a [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm592062.htm?ref=fdaweb.com) as part of its investigation of Vacutainer blood collection tubes used in Magellan Diagnostics LeadCare and LeadCare II blood lead testing systems, citing 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 6/2017, 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 Warning Letter said Becton Dickinson was marketing significantly modified versions of certain BD Vacutainer blood collection tubes without required FDA clearance or approval, and it failed to submit medical device reports within the required timeframe. The inspection also revealed that the company failed to evaluate and investigate a complaint involving variability in test results observed when the blood collection tubes were used with Magellan Diagnostics’ test systems.

FDA conducted its inspection of the BD facility as part of its [ongoing investigation](https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm572207.htm?ref=fdaweb.com) into the cause of inaccurate blood lead test results associated with Magellan’s LeadCare test systems. “We are continuing to aggressively investigate this issue, including whether the use of BD tubes led to inaccurate lead test results,” an [agency notice](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm592163.htm?ref=fdaweb.com) says.  

During the [inspection](https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM571749.pdf?ref=fdaweb.com), the agency says its investigators found evidence of numerous violations, including Becton Dickinson’s failure to notify the FDA about a significant change that the company made to the rubber stoppers for certain BD Vacutainer blood collection tubes that could significantly affect the safety or effectiveness of these devices. The inspection also found evidence that Becton Dickinson failed to comply with GMP requirements, such as device design validation requirements and for failing to adequately review, evaluate, and investigate complaints.