Events

Recall of Device Recall Clinitek

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bayer HealthCare LLC, Diagnostics Div.

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
    26312
  • Event Risk Class
    Class 2
  • Event Number
    Z-0911-03
  • Event Initiated Date
    2003-06-19
  • Event Date Posted
    2003-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27494
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Analyzer will produce erroneous results due to missing grounding strap.
  • Action
    Marketing sent a 'dear customer' letter to each account on May 13, 2003 telling them that their instrument had been identified as not meeting a production specification. An urgent product correction letter was subsequently sent to each account on or about June 20, 2003. The analyzers affected will be replaced.

Device

Device Recall Clinitek
  • Model / Serial
    serial numbers 168252 through 169574.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribution
    United States, Australia, Canada, Colombia, France, Germany, Hong Kong, India, Japan, Korea, Mexico, Sweden, Switzerland and United Kingdom.
  • Product Description
    Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The different product codes are for the various countries where the product is distributed.]
  • Manufacturer
    Bayer HealthCare LLC, Diagnostics Div

Manufacturer

Bayer HealthCare LLC, Diagnostics Div
  • Manufacturer Address
    Bayer HealthCare LLC, Diagnostics Div, 1884 Miles Ave., Elkhart IN 46515
  • Source
    USFDA