Events

Recall of Device Recall RapidLab1200 System

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

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
    34505
  • Event Risk Class
    Class 2
  • Event Number
    Z-0685-06
  • Event Initiated Date
    2006-01-20
  • Event Date Posted
    2006-03-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44157
  • 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
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph - Product Code CHL
  • Reason
    When stored data is recalled from memory, the results do not agree with the original results. software anomaly: a calculation error occurs when using the correlation adjustment feature on the rapidlab 1200 systems with software versions 1.0, 1.01, or 1.02. the correlation feature applies user-defined slope and offset parameters each time stored test results are recalled to the display.
  • Action
    Support Bulletins and Customer Bulletins were e-mailed to all Bayer HealthCare LLC Branches on 1/20/06 for distribution to the end user facilities (medical facilities).

Device

Device Recall RapidLab1200 System
  • Model / Serial
    All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hong Kong, Italy, Japan, Korea, Malaysia, The Netherlands, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland.
  • Product Description
    Brand Name: RapidLab 1200 System, Model 1265, Part Number 05063769; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test system.
  • Manufacturer
    Bayer Healthcare, LLC (Diagnostics Division)

Manufacturer

Bayer Healthcare, LLC (Diagnostics Division)
  • Manufacturer Address
    Bayer Healthcare, LLC (Diagnostics Division), 511 Benedict Avenue, Tarrytown NY 10591
  • Source
    USFDA