Events

Recall of Device Recall LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls

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
    77695
  • Event Risk Class
    Class 2
  • Event Number
    Z-3035-2017
  • Event Initiated Date
    2016-01-20
  • Event Date Posted
    2017-08-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157541
  • 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
    Leadcare ii test kits controls out of range.
  • Action
    Magellan notified customers initially by Email, fax and/or verbal communication with Magellan Product Support representatives beginning on January 20, 2016 to advise of the problem and provide revised Assignment Control Value Matrix..

Device

Device Recall LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls
  • Model / Serial
    Lot # :1507N Exp Date: 1/27/17; Lot # :1508N Exp Date: 2/27/17; Lot # :1510N Exp Date: 4/19/17; Lot # :1511M Exp Date: 5/3/17 Lot # :1511N Exp Date: 5/17/17 Lot # :1512M Exp Date: 6/2/17
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide - US Nationwide distribution and the countries of: COLOMBIA, CANADA, THAILAND, INDIA, UAE, AUSTRALIA, GERMANY, CANADA, SOUTH AFRICA, SPAIN, NEW ZEALAND, KOREA
  • Product Description
    LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls || Product Usage: || IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The LeadCare II Lead Controls packaged in the kit lots listed in #2 below are the subject of this recall (Field Correction) action.
  • 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