Events

Recall of Device Recall OBSERVA

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

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
    35518
  • Event Risk Class
    Class 2
  • Event Number
    Z-1161-06
  • Event Initiated Date
    2006-03-28
  • Event Date Posted
    2006-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46301
  • 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
    data managemen system - Product Code MDB
  • Reason
    Software problem with scanner inter-character delay which may result in false positive or false negative results after incorrect scanning of bottle id's.
  • Action
    The recalling firm telephoned customers who ordered the MB bottles and use the OBSERVA software ver. 2.0 to inform them of the issues. Recall letters were issued to all customers via overnight mail on 5/22/06 informing them a field representative would be visiting to make a short-term correction to the system. The letter also informed the customer a permanent correction to the software was scheduled for release later in the year.

Device

Device Recall OBSERVA
  • Model / Serial
    Software version R.02.00.17
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    WorldwideDistribution--Nationwide to medical centers. Government distribution was made to MN and CA, and military distribution was made to OK. Foreign distribution was made to Thailand, The Netherlands, Germany, Greece, Portugal, and France.
  • Product Description
    OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected to BacT/ALERT 3D
  • Manufacturer
    bioMerieux Inc

Manufacturer

bioMerieux Inc
  • Manufacturer Address
    bioMerieux Inc, 595 Anglum Rd, Hazelwood MO 63042-2320
  • Source
    USFDA