Recall of faulty lead poisoning test means kids need to be retested

There’s a chance that tests given to millions of kids since 2014 to detect lead poisoning didn’t work properly, delivering falsely low results to an unknown number of American families.

As many as 7 million tests performed on children over the course of the three years could have been wrong, according to the Centers for Disease Control and Prevention. The manufacturer of the tests in question, however, is confident the number is millions lower.

Parents may not realize that routine visits to the pediatrician should include a blood test to screen their child for lead. Among the barrage of questions about a baby’s development, physical exams, updates on shots and other tests, it can get glossed over – particularly if the test comes back negative. Read the full story from WTSP.

WHO IS AFFECTED?

Audiences:

• Laboratories that use Magellan’s LeadCare Testing Systems as part of diagnostic applications.
• Laboratory personnel who interpret the results of Magellan’s LeadCare Testing Systems.
• Health care professionals who perform lead tests using Magellan’s LeadCare Testing Systems.
• Patients being tested for elevated blood lead levels (BLL) with Magellan’s LeadCare Testing Systems, in particular children in high-risk environments with BLL in the 5 to14 micrograms per deciliter (µg/dl) range.

Medical Specialties:

Pediatrics, Family Medicine, Internal Medicine, Preventive Medicine, Obstetrics/Gynecology, Emergency Medicine, Clinical Pathology, Hematology/Oncology, Laboratory Medicine, Emergency Medicine, Occupational Health, Safety Specialists

Product:

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.

LINK: Read more on the specifics of the recall from the FDA.