FDA MedWatch - Risk of False Positive Results with Certain Capillary Blood Collection Tubes by Magellan Diagnostics LeadCare Testing Systems – FDA Safety Communication

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TOPIC: Risk of False Positive Results with Certain Capillary Blood Collection Tubes by Magellan Diagnostics LeadCare Testing Systems – FDA Safety Communication

AUDIENCE: Patient, Health Care Professional, Risk Manager, Laboratory

ISSUE: The FDA is alerting health care providers and laboratory staff of reports that falsely elevated (false positive) results have occurred when using ASP Global’s RAM Scientific SAFE-T-FILL Micro Capillary Blood Collection tubes with the LeadCare Testing Systems. These tests may overestimate blood lead levels and give inaccurate results when processing capillary blood samples collected in these ASP Global’s RAM Scientific SAFE-T-FILL tubes.

False test results may delay an accurate diagnosis and may lead to improper patient management and unnecessary follow-up tests (with additional risks), increased stress for patients and families, and disruptions in care. Timely and accurate detection of elevated lead levels is essential to prevent the harmful effects of lead poisoning and ensure patients receive the right care without delay.

The FDA is investigating the root cause of this issue with the manufacturers of the tests and collection tubes and will provide updates as critical information becomes available.

For more information about this alert, click on the red button "Read Alert" below.

BACKGROUND: The LeadCare, LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests are used to detect lead in a blood sample, which may be obtained from finger or heel prick (capillary). The LeadCare Testing Systems are used in clinical laboratories, doctor’s offices, clinics, and hospitals throughout the U.S.

RECOMMENDATIONS: 

• Avoid using ASP Global’s RAM Scientific SAFE-T-FILL Micro Capillary Blood Collection tubes with the LeadCare Testing Systems.

• The capillary collection devices that are provided with the LeadCare Test Systems as well as other third-party capillary blood collection tubes, as described in the instructions for use of LeadCare Testing Systems, can still be used.

• If no alternate capillary blood collection devices are available other than the ASP Global’s RAM Scientific SAFE-T-FILL Micro Capillary Blood Collection tubes, interpret results with caution and consider retesting with a different method or specimen type.

• Follow CDC’s recommendations for confirmatory venous blood testing based on blood lead levels observed in capillary blood lead tests (https://www.cdc.gov/lead-prevention/testing/index.html).

Health care 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.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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