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  Important Information Regarding the FDA Safety Notice May 17, 2017   

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Key Points

 

  • Venous blood samples should NOT be used on LeadCare products including LeadCare II.

Blood collection devices compatible with LeadCare Blood Lead Testing Systems
CDC's Flow Diagram for Determining the Need for Retesting

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On May 17, 2017, the FDA issued a public statement that venous blood samples should no longer be used on Magellan Diagnostics’ LeadCare Blood Lead Testing Systems due to concerns that some venous results, when analyzed on these systems, could be inaccurate. Due to the potential for harm of a false-negative blood lead test, the FDA has classified this as a Class I recall. Magellan is working closely with the FDA and hopes to have a resolution to this issue as quickly as possible.

The vast majority of tests run on LeadCare Systems use capillary samples, which are not affected by this recall.

 

  • Capillary blood samples are permitted and accurate. 

 

  • CDC recommends retesting children 0-6 years and pregnant women, if they had a venous blood sample tested on a LeadCare device with a result less than 10 µg/dL

Fax form record available for download