MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS, INC. LEADCARE II BLOOD LEAD TESTING SYSTEM; BLOOD LEAD ANALYZER

Catalog Number	70-6760
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2026
Type of Reportable Event	Malfunction

• Brand Name: LEADCARE II BLOOD LEAD TESTING SYSTEM
• Common Device Name: BLOOD LEAD ANALYZER
• Manufacturer (Section D): MAGELLAN DIAGNOSTICS, INC.; 101 billerica avenue, bldg. 4; north billerica MA 01862
• Manufacturer (Section G): MAGELLAN DIAGNOSTICS, INC.; 101 billerica avenue, bldg. 4; north billerica MA 01862
• Manufacturer Contact: john lewis ; 101 billerica avenue, bldg. 4; north billerica, MA 01862
• MDR Report Key: 25813973
• Report Number: 1218996-2026-00267
• Device Sequence Number: 20349748
• Product Code: DOF
• UDI-Device Identifier: 00850355006017
• UDI-Public: 00850355006017
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K052549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 70-6760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown