Events

Recall of Device Recall EasyRA Cuvette Segments for EasyRA Clinical Chemistry Analyzer

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

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
    55150
  • Event Risk Class
    Class 2
  • Event Number
    Z-0078-2011
  • Event Initiated Date
    2010-03-29
  • Event Date Posted
    2010-10-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90135
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    Chemistry analyzers may report calcium results below the sample's actual concentration. reported results may be ten to fifteen percent lower than expected sample results. the defect is a shortened path length at specific cuvette positions of those segments manufactured using molding cavity 1. the shortened path length was determined by measuring the cuvette dimensions with a co-ordinate measuri.
  • Action
    Medica issued an Urgent Product Recall letter dated March 29, 2010 to customers. Users were requested to cease using and discard the affected product, and complete and return a Response Form in order to obtain replacement product. Customers can contact Medica Technical Support at 877-777-5895.

Device

Device Recall EasyRA Cuvette Segments for EasyRA Clinical Chemistry Analyzer
  • Model / Serial
    Lot Numbers:  2009/A2810, 2009/A2910, 2009/A3010, 2010/A2001, 2010/A21 01, 2010/A1901, 2009/A0211, 2009/A0311
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, and the countries of Bulgaria, Canada, India, Mexico, Panama, Phillipines, Russia, Turkey, New Zealand, South Africa, United Arab Emirates, and Venezuela.
  • Product Description
    EasyRA Cuvette Segment 1, P/N 007000-001 || (In Vitro Diagnostic ) || EasyRA Cuvette Segments included in the following Kits: || EasyRA Cuvettes, REF 10700-4 || Startup Kit - Chemistry, REF 10990 || Startup Kit - Chemistry & ISE, REF 10991
  • Manufacturer
    Medica Corporation

Manufacturer

Medica Corporation
  • Manufacturer Address
    Medica Corporation, 5 Oak Park Dr, Bedford MA 01730
  • Manufacturer Parent Company (2017)
    Medica Corporation
  • Source
    USFDA