FDA MedWatch - LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests by Magellan Diagnostics:

Class I Recall - Due to Risk of Falsely Low Results

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 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.  RECOMMENDATIONS: On May 28, 2021, Magellan notified distributors through phone calls and on June 7, 2021 sent customers an Urgent Medical Device Recall letter requesting product removal of specific lots. On June 23, 2021, Magellan notified customers by phone the recall has been expanded to include additional lots.  At this time, Magellan has reported that three lots of test kits which were previously distributed to customers are not impacted by this recall. Laboratories or health care providers who currently have LeadCare II lots 2012M, 2018M, and 2102M in their inventory may continue to use these tests. Customers and distributors are instructed to also take the following actions: Customers: 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. Be aware, product will be replaced based on availability; replacement product is NOT currently available. Distributors: Stop distribution of LeadCare blood lead test kits identified as part of the recall; review current inventory and quarantine any remaining stock. Be aware, the product will be replaced based on availability; replacement product is NOT currently available. Provide to Magellan a distribution list of customers that have received the impacted product. 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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