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	03/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer (a biomedical engeneer; not the end user) reported discrepant blood lead test results obtained from two different leadcare ii analyzers for the same patient.Quality controls were reported within range; however, specific control values and reagent lot information were not provided.The customer reported that the analyzer serial number: (b)(6) produced a blood lead test result of 8.3 g/dl, while a second leadcare ii analyzer produced a result of approximately 5.5 - 5.8 g/dl.The serial number for the second analyzer has not been provided.Technical support (ts) inquired whether repeat testing was performed using a newly collected patient sample or by using original sample leftover in the treatment reagent vial.Ts also asked whether confirmatory venous blood testing had been conducted on the patient.Ts requested end-user contact information.The customer indicated they would visit the end-user site on (b)(6) 2026 and obtain additional details.On (b)(6) 2026, the customer reported that the testing site supervisor was unsure whether the second test result was obtained from a recollected sample or a rerun of the original in the treatment regent vial.The sample was reportedly retested due to the initial elevated result; the site indicated that routine reruns are not typically performed.Follow up attempts by ts: 03/18/2026: requested additional information via email.03/23/2026: voicemail left.03/30/2026: follow-up email requesting end-user contact information.On (b)(6) 2026, the customer reported they are attempting to have a clinic representative contact ts or provide a direct phone number for follow-up.

• 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: 24809982
• Report Number: 1218996-2026-00125
• Device Sequence Number: 10707309
• Product Code: DOF
• UDI-Device Identifier: 00850355006017
• UDI-Public: 00850355006017
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/07/2026

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: 03/18/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown