Events

Recall of Product is in2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P (Test Cartridges) which may then be packaged as a consumables pack (902079D) or a starter pack (901077N). Product is labeled in part: ''in2it In-Office analyzer A1C Test Cartridges***For the rapid quantification of hemoglobin A1c in whole blood***Provalis Diagnostics***.''

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Provalis Diagnostics.

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
    32571
  • Event Risk Class
    Class 2
  • Event Number
    Z-0171-06
  • Event Initiated Date
    2005-05-20
  • Event Date Posted
    2005-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40371
  • 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
    Provalis diagnostics discovered, following its internal stability testing program (mid-point batch testing), that occasional low values were being found across multiple lots of in2it hba1c test cartridges.
  • Action
    All consignees were initially notified by telephone with followup by FAX or email. Users/Distributors may also be visited by Provalis Sales Staff.

Device

Product is in2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P (Test Cartri...
  • Model / Serial
    Device Lot 03793, 03952, 04080, 04128, 04208, 04209, 04321, 04323, 04464, 05040.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to 7 Consignees in the US one each in FL, KY, IL, LA, MI, AZ, GA.
  • Product Description
    Product is in2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P (Test Cartridges) which may then be packaged as a consumables pack (902079D) or a starter pack (901077N). Product is labeled in part: ''in2it In-Office analyzer A1C Test Cartridges***For the rapid quantification of hemoglobin A1c in whole blood***Provalis Diagnostics***.''
  • Manufacturer
    Provalis Diagnostics

Manufacturer

Provalis Diagnostics
  • Manufacturer Address
    Provalis Diagnostics, 7380 W Sand Lake Rd Ste 500, Orlando FL 32819-5257
  • Source
    USFDA