MAUDE Adverse Event Report: Magellan Diagnostics, Inc. LeadCare II Blood Lead Testing System; Blood Lead Analyzer

Catalog Number	70-6760
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2026
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: 50934869
• Report Number: 1218996-2026-00422
• Device Sequence Number: 9526027
• Product Code: DOF
• UDI-Device Identifier: 00850355006017
• UDI-Public: 00850355006017
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K052549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown