Events

Recall of Device Recall LeadCare II Blood Lead Analyzer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Magellan Diagnostics, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79279
  • Event Risk Class
    Class 2
  • Event Number
    Z-1295-2018
  • Event Initiated Date
    2018-01-09
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161821
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Lead, atomic absorption - Product Code DOF
  • Reason
    The incorrect placement of aa batteries into certain leadcare ii blood lead analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are removed while hot.
  • Action
    An Urgent Medical Device Correction letter, dated January 9, 2018, was sent to customers. The letter identified the affected device and provided a description of the issue. If two of the four AA batteries are inserted incorrectly, the batteries may overheat, causing a minor burn if the user opens the battery compartment and tries to remove the hot batteries. Customers are to follow the steps outlined in the letter, including placing the enclosed label on the upper back panel of the analyzer to remind users who are changing batteries of the importance of correct placement. Proper battery placement should be provided in annual training. Customers are to complete and return the acknowledgement card. Please direct any questions to 800-275-0102 or LeadCareSupport@magellandx.com.

Device

Device Recall LeadCare II Blood Lead Analyzer
  • Model / Serial
    Part Numbers: 70-6760, 70-6529-R, 70-6760-P, and  70-6760-R. All LeadCare II and LeadCare Plus Blood Lead Analyzers with battery boards versions B and O.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    LeadCare II Blood Lead Analyzer || Part Numbers: 70-6760, 70-6529-R, 70-6760-P, || 70-6760-R. || Intended for in vitro (external) use only.
  • Manufacturer
    Magellan Diagnostics, Inc.

Manufacturer

Magellan Diagnostics, Inc.
  • Manufacturer Address
    Magellan Diagnostics, Inc., 101 Billerica Ave Bldg 4, North Billerica MA 01862-1271
  • Manufacturer Parent Company (2017)
    Meridian Bioscience, Inc.
  • Source
    USFDA