FDA Alert on False Positive Lead Tests

FDA is alerting health care providers about reports of falsely elevated (false positive) results that have occurred when using ASP Global’s RAM Scientific SAFE-T-FILL Micro Capillary Blood Collection tubes with 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,” an agency notice says. Because the root cause is not yet known, FDA is recommending that the tubes not be used with the LeadCare Testing Systems while the issue is being investigated.

“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,” the notice says. The LeadCare tests are used to detect lead in a blood sample, which may be obtained from finger or heel prick (capillary).