Events

Recall of Device Recall ACCUCHECK FastClix

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Diagnostics Operations, 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
    65886
  • Event Risk Class
    Class 2
  • Event Number
    Z-2109-2013
  • Event Initiated Date
    2013-08-19
  • Event Date Posted
    2013-08-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121209
  • 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
    Lancet, blood - Product Code FMK
  • Reason
    Internal roche inspections have revealed that after the lancet is used for a finger stick, the needle may not fully retract back within the lancet drum or back into the cap. this allows the needle to protrude inside the cap or outside of the cap of the accu-chek fastclix lancing device.
  • Action
    On 8/19/ 2013, Roche sent Distributor/Retailer URGENT MEDICAL DEVICE CORRECTION notifications which described the recall issue and health consequences, provided product description, and provided actions required of consignees. Roche sent a CUSTOMER BULLETIN to their direct customers. URGENT MEDICAL DEVICE CORRECTION faxback form for consignee acknowledgement of recall is to be faxed to 1-888-240-2804. Consignees may contact the ACCU-CHEK Customer Care Service Center, 24 hours a day, seven days a week at 1-800-440-3638 if they have questions about the information contained in the Distributor/Retailer Letter.

Device

Device Recall ACCUCHECK FastClix
  • Model / Serial
    Lot Number(s): GDA 048, GDA050, GDA 051, GDA 063
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • Manufacturer Address
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    USFDA