FDA Oct 24, 2023
LeadCare II Blood Lead Test Kit
Catalog Number 70-6762 Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.
On May 17, 2021, Magellan issued an Urgent Medical Device Removal notice to customers and distributors via letter notifying them Magellan has identified an ongoing issue with testing of the controls included in specified lots of LeadCareII Blood Lead Test Kits, LeadCare Plus Blood Lead Test Kits, and LeadCare Ultra Blood Lead Test Kits.
REQUIRED ACTIONS:
LeadCare blood lead test kits, Catalog Numbers: 70-6762, 82-0004, and 70-8098
- Per laboratory policies and procedures, laboratories should evaluate patient test results that were generated with the impacted lots.
- Magellan is recommending retesting of suspect results below 5 mg/dL.
- All blood Lead test results should be shared with the patient s physician for interpretation and to determine
when retesting and follow-up care are necessary.
- Review current inventory and segregate any remaining stock.
- Discontinue use of any remaining stock.
- Contact Magellan Technical Support 1-800-275-0102 to obtain a FedEx label to return any remaining inventory to Magellan Diagnostics, Inc. and receive replacement product (replacement product is currently available).
- Promptly complete and return the Customer Notification Form (this will indicate receipt of this field correction notice). Complete this form even if you have no remaining inventory.
On June 23, 2021, Magellan expanded their recall to include an additional product lot by placing telephone calls to the primary distributors. Magellan will issue an Expanded Urgent Medical Device Recall notice to all impacted customers via certified mail starting June 30,2021. Customers are advised to review inventory, segregate and discontinue use of all impacted products. Therefore, patient testing should not be performed (using any of the impacted lots) until resolution of the issue.
Immediate Actions:
- Review current inventory and segregate any remaining stock.
- Discontinue use of any remaining stock.
- Promptly complete and return the Customer Notification Form below t