Events

Recall of Device Recall Variant II Turbo

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
    54684
  • Event Risk Class
    Class 2
  • Event Number
    Z-1898-2011
  • Event Initiated Date
    2009-12-08
  • Event Date Posted
    2011-04-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89009
  • 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
    Assay, glycosylated hemoglobin - Product Code LCP
  • Reason
    Wrong lot number was found on the hemoglobin cartridge insert . the insert did not match the lot number to the device cartridge or the device cartridge label or on the update kit cd.
  • Action
    The firm, Bio-Rad, sent a "MEDICAL DEVICE CORRECTION" letter dated November 29, 2009 to all customers by Federal Express. The letter described the product, problem and action to be taken. The customers were instructed to do the following: 1) If their Lot No. LV90170B VARIANT II TURBO Hemoglobin A(10) Cartridge Set includes an insert referencing Lot No. 80080, please destroy the insert and use the new insert enclosed with the letter. 2) If their Lot No. LV90170B VARIANT II TURBO Hemoglobin A(10) Cartridge Set includes an insert referencing Lot No. 90170, they may continue using the insert. 3) Complete and return the attached CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM via fax to: Bio-Rad CSD Regulatory Affairs Department at (510) 741-3954. If you have any questions, please call 510-724-7000 or contact your regional Bio-Rad office.

Device

Device Recall Variant II Turbo
  • Model / Serial
    Model Number(s): 270-2417 (Kit), with 270-2420 (Cartridge set) Code(s): LCP Listing Number(s): DO48707 for CDM 3.6T software Expiration date(s): Lot 70292242 EXP. Mar 31, 2010 and Lot 70292318 EXP. Jan. 31, 2010
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: CA, CT, GA, IL, IN, MA, ME, MS, NH, NV, OH, PA, TX, VA and WV; and countries including: France, Hong Kong, Italy, Korea and New Zealand.
  • Product Description
    Device brochure, labeled in part : BIO -RAD***L70242709 VARIANT TM II TURBO***Hemoglobin A 1C***Cartridge Set, Cartridge Set, Analytical Cartridge, Guard Cartridge Insert***UNITED STATES, Bio-Rad Laboratories, Inc. Hercules, CA 94547***" || Integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood.
  • 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