MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS, INC. LEADCARE II TEST KIT; LEAD, ATOMIC ABSORPTION

Lot Number 2018M

Device Problem Nonstandard Device (1420)

Patient Problem Insufficient Information (4580)

Event Date 07/06/2021

Event Type  malfunction  

Event Description

Magellan leadcare ii test kit recall.

• Brand Name: LEADCARE II TEST KIT
• Type of Device: LEAD, ATOMIC ABSORPTION
• Manufacturer (Section D): MAGELLAN DIAGNOSTICS, INC.; n. billeria MA 01862
• MDR Report Key: 12933990
• MDR Text Key: 281910006
• Report Number: MW5105800
• Device Sequence Number: 1
• Product Code: DOF
• UDI-Device Identifier: 00850355006000
• UDI-Public: 0100850355006000
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2022
• Device Lot Number: 2018M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: MAGELLAN LEADCARE II TEST KIT: (B)(6) 2021-(B)(6) 2021
• Patient Age: 2 YR
• Patient Sex: Male
• Patient Weight: 14 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White