Events

Recall of EasyCAL HbA1c Calibrator

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
    77160
  • Event Risk Class
    Class 2
  • Event Number
    Z-1267-2018
  • Event Initiated Date
    2017-04-11
  • 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=155111
  • 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
    Calibrator, secondary - Product Code JIT
  • Reason
    Patient results determined using this calibrator lot might deviate up to 20%. controls might not indicate false values.
  • Action
    Consignees were notified of the recall via email bulletin dated 4/11/17. The bulletin informs customers of the issues and explains the actions to be taken.

Device

EasyCAL HbA1c Calibrator
  • Model / Serial
    Medica s Lot # 16292
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA: MI FL CA TX India, Russia, Puerto Rico, N. Mariana Island/Palau.
  • Product Description
    EasyCAL HbA1c Calibrator; REF 10658 || Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet.
  • Manufacturer
    Medica Corporation

Manufacturer

Medica Corporation
  • Manufacturer Address
    Medica Corporation, 5 Oak Park Dr, Bedford MA 01730-1430
  • Manufacturer Parent Company (2017)
    Medica Corporation
  • Source
    USFDA