Events

Recall of Device Recall BioPlex 2200

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bio-Rad Laboratories 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
    45892
  • Event Risk Class
    Class 2
  • Event Number
    Z-0575-2008
  • Event Initiated Date
    2007-11-13
  • Event Date Posted
    2008-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-07-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66439
  • 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
    automated immunodiagnostic analyzer software - Product Code NVI
  • Reason
    Incorrect values: an error was found in the bioplex 2200 software, version 2.0 that results in assignment values being utilized for the bioplex assay calibrator set that may be slightly different from those printed on the value assignment data sheet. some values may be identical between the lot assignment combinations with the ana screen with mdss kit.
  • Action
    Bio-Rad sent a Voluntary Field Correction notice dated November 1, 2007. Consignees were notified by phone call on Nov. 13, 2007, followed up by facsimile (domestic). Sub-recall to be by e-mail message for consignees outside the US. Distribution of the product ceased on Nov. 2, 2007. Bio-Rad will provide Calibrator Set CDs with only one lot of calibrator assignment values until a new version of software is available.

Device

Device Recall BioPlex 2200
  • Model / Serial
    All software version 2.0, used with Calibrator Lots 86280 and 86290.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, Canada, France, and Germany.
  • Product Description
    BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic analyzer, Bio-Rad Laboratories, Inc., Hercules, CA 94547
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc
  • Manufacturer Address
    Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Source
    USFDA