Safety

LeadCare Testing Systems (with Blood Obtained from a Vein) by Magellan Diagnostics: FDA Safety Communication - Risk of Inaccurate Results

UPDATED 07/13/2017. Statement from Alberto Gutierrez, Ph.D., Director, Office of In Vitro Diagnostics and Radiological Health, FDA’s Center for Devices and Radiological Health on the status of FDA’s investigation into inaccurate results from certain lead tests, including release of inspection report.

UPDATED 06/06/2017. Class I Recall expanded to include two additional testing systems; LeadCare and LeadCare II Blood Lead Testing Systems (all serial and lot numbers).

UPDATED 05/25/2017.  Class I recall issued for LeadCare Plus and Ultra Testing Systems (all serial numbers, all kit lot numbers). Magellan Diagnostics is recalling the LeadCare Plus and the LeadCare Ultra Testing Systems because they may underestimate the blood lead levels (BLL) and give inaccurate results when processing venous blood samples. Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning. The use of affected product may cause serious adverse health consequences.

Magellan's LeadCare Plus and Ultra Testing Systems are two of four blood lead testing systems affected by the recommendations in FDA's safety communication.

The FDA is unable to identify the root cause for the inaccurate results, based on data provided by Magellan. FDA is conducting studies with the Center for Disease Control and Prevention (CDC) to identify the cause and better characterize the extent of the problem.

  • Manufacturing Dates: September 2013 to Present
  • Distribution Dates: September 2014 to Present
  • Devices Recalled in the U.S.: 1,089,984 systems nationwide

 

[Posted 05/17/2017]

AUDIENCE: Pediatrics, Risk Manager, Laboratory, Family Practice

ISSUE: The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are warning Americans that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the United States. Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning.

The FDA is unable to identify the root cause for the inaccurate results, based on data provided by Magellan. We are conducting studies with the CDC to identify the cause and better characterize the extent of the problem. At this time, the FDA has no evidence that Magellan’s LeadCare Testing Systems have the same problem when processing capillary blood samples. The FDA is aggressively investigating the root cause of this issue with the manufacturers, health care facilities and the CDC, and will update this safety communication as critical information becomes available.  For more information please refer to the Safety Communication.

BACKGROUND: Magellan Diagnostics Inc. manufactures the following lead testing systems affected by this warning: LeadCare, LeadCare II, LeadCare Plus, and LeadCare Ultra.

The LeadCare Testing Systems detect the amount of lead in a blood sample obtained from finger or heel prick (capillary) or from a vein (venous). This warning applies to all four Magellan Diagnostics LeadCare Testing Systems when processing venous blood samples, in the United States.

Note: Magellan's LeadCare II is a point-of-care (CLIA-waived) blood lead testing system on which users mostly test capillary blood samples. However, some laboratories also process venous blood samples with the LeadCare II system, which is why this safety communication includes all Magellan LeadCare Testing Systems.

The LeadCare Testing Systems are used in clinical laboratories, doctor’s offices, clinics, and hospitals throughout the U.S.

RECOMMENDATION: The FDA recommends laboratories and health care professionals take the following actions:

  • Discontinue using Magellan's LeadCare System Testing Systems with venous blood samples. At this time, all LeadCare systems can be used with capillary blood samples.
  • If laboratories or health care professionals are concerned about using the LeadCare Test Systems, the alternative options are mass spectrometry or atomic absorption methods. These are not point-of-care tests, and may be available only from larger-capacity laboratories such as reference labs.
  • This Safety Communication replaces all previous communication from Magellan Diagnostics on their LeadCare lead testing systems including Magellan's most recent Field Safety Correction Notification dated April 28, 2017.

    The CDC recommends that parents of children younger than six years (72 months) of age, and currently pregnant women and nursing mothers who have been tested for lead exposure consult a health care professional about whether they should be retested.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

[07/13/2017 - CDRH Statement - FDA]

[07/13/2017 - Inspection Report - FDA]

[06/05/2017 - Recall Notice - FDA]

[05/25/2017 - Recall Notice - FDA]

[05/17/2017 - Safety Communication - FDA]

[05/17/2017 - Press Release - FDA]

 

Page Last Updated: 07/13/2017
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