Events

Recall of Device Recall BioPlex 2200 EBV IgG Calibrator Set.

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
    58291
  • Event Risk Class
    Class 2
  • Event Number
    Z-2082-2011
  • Event Initiated Date
    2011-03-11
  • Event Date Posted
    2011-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98905
  • 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
    Epstein-barr virus, other - Product Code LSE
  • Reason
    Bio-rad laboratories confirmed a downward shift in control values for ebv na-1 analyte when using the bioplex 2200 ebv igg calibrator set lot #46704.
  • Action
    The firm, Bio-Rad Laboratories, sent an "Voluntary Field Correction: BioPlex 2200 EBV IgG Calibrator Set, Lot# 46704 for EBV NA-1 Analyte" letter dated March 16, 2011 domestic customers via Fed-Ex and and to international subsidiaries via e-mail. The letter described the product, problem and actions to be taken. The consignees/customers were informed that Bio-Rad confirmed downward shift in control values for the EBV NA-1 analyte when using the BioPlex 2200 EBV IgG Calibrator Set, Lot # 46704. If this occurs, the customers were instructed to readjust the positive control mean using the procedure presented in the customer notification "BioPlex 2200 Quality Control Values (L60013402)". If the re-adjusted mean of the EBV NA-1 controls is within the manufacturer's limit, patient results may be reported. If the new assay positive control mean still does not fall within the manufacturer's limit, the customers were instructed to contact their local Bio-Rad Technical Support and do not report the EBV NA-1 values. The customers were also instructed to complete and return the CUSTOMER RESPONSE FORM via fax to 510-741-5775. If the BioPlex 2200 EBV VCA IgG and EBV EA-D IgG positive and negative control means are within the acceptable QC range, and subsequent passing QC runs are obtained, patient results may be reported for these analytes. Bio-Rad will be manufacturing a new lot of the BioPlex 2200 EBV IgG Calibrator Set which will bring the control values within the manufacturer's limit. It may be necessary to readjust the QC ranges after the consignees receive this new calibrator set lot. Bio-Rad will send their consignees/customers the replacement calibrators and calibrator CDs when available. The consignees/customers were also instructed to discard the calibrator set lot# 46704 in accordance with national and/or local regulations. Customers can call Clinical Diagnostics Group at 510-741-4431 or email to BPD-ProductSupport@bio-rad.com for any questions

Device

Device Recall BioPlex 2200 EBV IgG Calibrator Set.
  • Model / Serial
    Lot #46704.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including the following states: AL, AZ, CA, CT, FL, GA, HI, IL, IN, LA, MA, MD, MI, MN, NC, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and WI; and countries of: Australia, Czech Republic, France, Germany, Italy and Republic of Korea.
  • Product Description
    BioPlex 2200 EBV IgG Calibrator Set. Catalog #663-1200. || Product is labeled in part: "BIO-RAD***BioPlex 2200 EBV IgG Calibrator Set***7 x 0.5 mL***A Calibrator set for the BioPlex 2200 EBV IgG Reagent Pack***UNITED STATES, Bio-Rad Laboratories, Inc., Hercules, CA 94547". || BioPlex 2200 EBV IgG Calibrator Set is intended for the calibration of the BioPlex 2200 EBV IgG Reagent Pack.
  • 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