Events

Recall of Device Recall Image Upgrade Kit, Catalog 92019C

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

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
    66293
  • Event Risk Class
    Class 3
  • Event Number
    Z-0032-2014
  • Event Initiated Date
    2013-08-20
  • Event Date Posted
    2013-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122026
  • 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
    Test, hepatitis b (b core, be antigen, be antibody, b core igm) - Product Code LOM
  • Reason
    The fse image upgrade kit (part 92019c) is recalled due to issue related to the export of data from the evolis analyzer to laboratory information systems (lis) when using the monolisa anti-hbs eia quantitative determination in evolis apf version 6.0.
  • Action
    BioRad has sent an Urgent Product Correction letter dated August 19, 2013, to customers who had the EVOLIS FSE Upgrade Image Kit installed on the EVOLIS at their site by a Bio-Rad Laboratories Field Service Engineer (FSE). This issue impacts laboratory only if you are running the MONOLISA Anti-HBs EIA Quantitative Determination method with EVOLIS APF version 6.0 and TimeLiner Data Management Software. If you use this Quantitative Determination method with EVOLIS APF version 6.0, please contact Bio-Rad Laboratories for additional information or assistance. Bio-Rad Laboratories is currently developing and qualifying a software update CD consisting of the EVOLIS APF V6.0b and Timeliner Data Management Software to correct the issue. The software update CD will be installed by Bio-Rad Field Service Engineers at each of the customer sites when installing the EVOLIS APF V6.0b. Customers should contact Bio-Rad Laboratories at 1-800-224-6723, Option 2 and then Option 3 for any questions about this product correction.

Device

Device Recall Image Upgrade Kit, Catalog 92019C
  • Model / Serial
    Lot 122822
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA
  • Product Description
    FSE Image Upgrade Kit, Catalog # 92019C || This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
  • Manufacturer
    Bio-Rad Laboratories

Manufacturer

Bio-Rad Laboratories
  • Manufacturer Address
    Bio-Rad Laboratories, 6565 185th Ave NE, Redmond WA 98052-5039
  • Manufacturer Parent Company (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA