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	Insufficient Information (4580)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported elevated patient test results while using the leadcare ii (lcii) system.Customer contacted technical support (ts) in response to in response to the magellan field action 1218996-01/28/2026-0001c (leadcare labeling changes), associated crn-(b)(4).The customer reported that elevated patient blood lead level results were observed using the lcii system, but the elevated levels were not confirmed with subsequent confirmation testing.Ts requested additional information including the kit lot number(s) used, a list of elevated lcii results, and a list of the confirmation test results.The customer declined to provide this information.Ts advised the customer to follow center for disease control (cdc) guidelines as well as the instructions included in the lcii package insert.The customer reported familiarity with cdc guidelines, and declined to receive additional resources to be sent via e-mail.The customer confirmed that microtainer tubes were not used for capillary collection; only the capillary tubes included in the kit were utilized.Customer reported the controls are in range.The customer declined to provide any additional information regarding the elevated results, stating that such occurrences are infrequent.The customer declined additional follow-up and expressed satisfaction with the assistance provided by ts.Ts documented and escalated the event for possible mdr.

• 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: 24796051
• Report Number: 1218996-2026-00124
• Device Sequence Number: 13134680
• 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): 03/06/2026

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
• Device Lot Number: WLC18907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2024
• 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