Events

Recall of Device Recall D10 Dual Program, Update Kit D10 A1c program diskette

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
    66947
  • Event Risk Class
    Class 3
  • Event Number
    Z-0965-2014
  • Event Initiated Date
    2013-11-22
  • Event Date Posted
    2014-02-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124274
  • 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
    D-10 a1c dual program floppy was programmed incorrectly and cartridge injections counts are not being updated correctly when switching between the d-10 dual short program and extended program on the d-10 hemoglobin testing system.
  • Action
    BIO-RAD sent an Urgent Medical Device Correction letter dated November 22, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to continue to use the affected update kit disk(s) included with the reorder pack(s), but manually track the number of injections on the cartridge, reviewing QC results closely throughout the life of the reorder pack or destroy the affected disk(s) included with these reorder pack(s) and replace with the new Update Kit disk(s) The new Update Kit disks will elminate the problem and may be used with all reorder packs. The replacement disks do not contain reagent or calibrator information; after installing teh new Update Kit disk, they ust manually update the component information using instructions provided with the disk. For questions regarding this recall call 510-741-6265.

Device

Device Recall D10 Dual Program, Update Kit D10 A1c program diskette
  • Model / Serial
    Catalog number: 220-0201: Reorder Pack Lot No./Expiration date: 20030322 3/31/2014 20030337 3/31/2014 64000081 5/31/2014  64000331 5/31/2014  64000332 5/31/2014 64000888 08/31/2014 64001344 04/30/2014 64002239 11/30/2014   ( 64002240 08/3112014  64002241 11/30/2014
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Latin America, Asia Pacific, Canada, Australia, New Zealand and India.
  • Product Description
    D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. || United States; Bio-Rad Laboratories, || Hercules, CA 94547 || The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale} in whole blood. The separation is based on the principles of high performance liquid chromatography.
  • Manufacturer
    Bio-Rad Laboratories, Inc.

Manufacturer

Bio-Rad Laboratories, Inc.
  • Manufacturer Address
    Bio-Rad Laboratories, Inc., 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Manufacturer Parent Company (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA