| | MedWatch - The FDA Safety Information and Adverse Event Reporting Program | | | TOPIC: LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests by Magellan Diagnostics: Class I Recall - Due to Risk of Falsely Low Results AUDIENCE: Patient, Health Professional, Risk Manager, Laboratory ISSUE: Magellan Diagnostics is recalling its LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests due to a significant risk of falsely low results. The FDA has significant concerns that the performance of the test may provide falsely low results and may lead to health risks in special populations such as young children and pregnant individuals. A pregnant or lactating individual's exposure to lead is concerning because it not only may cause health problems for the parent but can result in lead exposure to the developing baby. Obtaining falsely low results may lead to patient harm including delayed puberty, reduced postnatal growth, decreased IQ, and inattention and behavior problems in children. For more information and detailed instructions about this recall, click on the red button "Read Recall" below. BACKGROUND: - The LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests are used to find out a person's blood lead level. The test uses a finger or heel stick whole blood (capillary) sample. After the sample is mixed with treatment reagent, a LeadCare analyzer measures the amount of lead collected on a sensor.
- Magellan's LeadCare II is a point-of-care (CLIA-waived) blood lead testing system. The LeadCare systems are used in clinical laboratories, doctor's offices, clinics, and hospitals throughout the United States.
RECOMMENDATIONS: - Discontinue use of all test kit lots identified as part of the recall and quarantine remaining inventory.
- Laboratories should evaluate patient test results that were generated with the impacted lots.
- Confirm suspect results with an alternative lead testing option, such as those using inductively coupled plasma mass spectrometry or graphite furnace atomic absorption spectroscopy at a high complexity, CLIA-certified, reference laboratory.
- Refer to retesting recommendations from the CDC
- Be aware, product will be replaced based on availability. Magellan Diagnostics has resumed distribution of the LeadCare II product, which was previously unavailable. LeadCare Plus and LeadCare Ultra products are currently unavailable
| | | Health 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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