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	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported seeing elevated blood lead test results with leadcare ii.Magellan technical services (ts) requested information regarding this issue, such as test kit lot number, test result values and corresponding confirmation test results.However, customer expressed frustration with the leadcare ii system and was unwilling to provide any details to ts or move foward with troubleshooting.Customer requested return of leadcare ii system.Ts notified magellan and sales team.

• 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: vernon brown ; 101 billerica avenue, bldg. 4; north billerica, MA 01862 ; 9789543699
• MDR Report Key: 24613760
• Report Number: 1218996-2026-00119
• Device Sequence Number: 21226485
• Product Code: DOF
• UDI-Device Identifier: 00850355006017
• UDI-Public: 00850355006017
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/16/2026
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown