Events

Recall of Device Recall in2it Self Test System A1c Test Cartridge

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
    56503
  • Event Risk Class
    Class 2
  • Event Number
    Z-0122-2011
  • Event Initiated Date
    2010-07-26
  • Event Date Posted
    2010-10-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93797
  • 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, glycoslylated hemoglobin - Product Code LCP
  • Reason
    Inaccurate results with high bias-- inaccurate results may be read by the machine, creating the risk for untreated hypoglycemia at elevated altitudes.
  • Action
    BIO-RAD Laboratories Deeside Ltd., sent an URGENT: MEDICAL DEVICE CORRECTION letter, dated July 26, 2010, to their subsidiaries and to all customers identifying the product, the problem, and the action to be taken. Subsidiaries were to ensure that all customers received the letter with the Customer Medical Device Correction Response Form and collect the completed form from every customer. Once forms were received from all customers they were to be faxed to BIO-RAD Deeside Regulatory Affairs at +44 (0) 1244833401. Customers were instructed to run a test and visually inspect the test cartridge to detect any residual clear liquid. If the cartridge did not run properly the test was to be rejected. Customers were to run Quality Control test with each new shipment of test cartridges. Patient's results were not to be reported if the QC failed. Customers were to complete the CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM and fax it to the number provided on the form. For questions customers were to contact their regional BIO-RAD office.

Device

Device Recall in2it Self Test System A1c Test Cartridge
  • Model / Serial
    Catalog numbers 281-0001EX, 281-0001, and 281-0001ST, all product manufactured sinc 2007-09-20.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to Bio-Rad's US subsidiary, along with 18 other distribution subsidiaries outside the US. These distributed further to other consignees. POroduct was distributed to Mexico, Korea, Singapore, Italy, South Africa, India, Australia, Spain, Greece, France, Thailand, Germany, New Zealand, China, Hong Kong, Portugal, Czech Republic, United Kingdom, Canada, Russia, Netherlands, Taiwan, Austria, Denmark, Israel, Finland and Belgium as well as to other African and Latin American countries.
  • Product Description
    in2it (I) and (II) System A1c Test cartridges and in2it Self Test System A1c Test Cartridges, for use with the in2it (I) and (II) self test system analyzer, manufactured by Bio-Rad, Flintshire, UK || The in2it (I) and (II) is an affinity chromatography method and is intended for the in-vitro quantitative determination of A1c in capillary blood taken from a finger prick. The test is indicated for monitoring the time averaged blood Glucose levels of known diabetics, for professional use as an indicator of overall glycemic control. The in2it (I) assay is intended for use in a physicians/doctors' office, the in2it (II) is intended for home use. The in2it Self Test system in intended for testing blood taken from a fingerstick. The test system is for self testing and for in-vitro diagnostic use only (not to be swallowed). The system shows how good glucose control has been over a two to three month period. The test system is the same as the test that has been CE marked for use in a clinical laboratory. The instructions for use have been changed with suggestions from people with diabetes. A patient study was conducted where untrained users ran their own blood tests and produced results which were as accurate as results obtained by trained users.
  • 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