Events

Recall of Calcitonin ELISA Kit

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

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
    69621
  • Event Risk Class
    Class 2
  • Event Number
    Z-0467-2015
  • Event Initiated Date
    2014-09-18
  • Event Date Posted
    2014-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131165
  • 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
    Radioimmunoassay, calcitonin - Product Code JKR
  • Reason
    A potential issue with false high values.
  • Action
    An Urgent Field Safety Notice dated 9/18/14 was sent to all their customers who purchased the Calcitonin ELISA Kit. The letter informed the customers of the problems identified and the actions to be taken. Customers were to examine their inventory immediately and quarantine any affected product. Also, customers were asked to notify any customers that the product was further distributed to. Customers with questions were instructed to contact their local Customer Service or Sales Representative regarding the recall notification. Customers were instructed to complete and return the enclosed response form by either fax or email as soon as possible and not later than 10/1/14.

Device

Calcitonin ELISA Kit
  • Model / Serial
    Lot No. 2041, 2071, 2089, 2124, 2167, 2178, 2180.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including the states of NH, CA, NJ, FL; and, the countries of Russia, Ukraine, Switzerland, Spain, Italy, Serbia, China, France, Pakistan, Austria, United Kingdom, Egypt, and India.
  • Product Description
    Calcitonin ELISA Kit, Code No. 7024, 7024BU. || Intended use of this product is the quantitative determination of Calcitonin in human serum.
  • Manufacturer
    Biomerica

Manufacturer

Biomerica
  • Manufacturer Address
    Biomerica, 17571 Von Karman Ave, Irvine CA 92614-6207
  • Manufacturer Parent Company (2017)
    Biomerica, Inc.
  • Source
    USFDA