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

Lot Number 2015-M

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2021

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: 12359050
• MDR Text Key: 268069434
• Report Number: MW5103431
• Device Sequence Number: 1
• Product Code: DOF
• 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: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2022
• Device Lot Number: 2015-M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 8