Events

Recall of Device Recall ARCHITECT CPeptide Reagent Kit

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

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
    59335
  • Event Risk Class
    Class 2
  • Event Number
    Z-3031-2011
  • Event Initiated Date
    2011-07-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102319
  • 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
    Radioimmunoassay, c-peptides of proinsulin - Product Code JKD
  • Reason
    C-peptide lots 03610k000 and 01711a000 have the potential to generate falsely elevated results with certain patient samples and with non-abbott controls.
  • Action
    Abbott Laboratories sent a "PRODUCT RECALL" letter dated July 11, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the lots and destroy any remaining inventory of the lots according to laboratory procedures. A Customer Reply form was provided to customers to complete and return via fax at 1-800-777-0051. Customers can contact Abbott Customer Service at 1-877-4ABBOTT for questions regarding this notice.

Device

Device Recall ARCHITECT CPeptide Reagent Kit
  • Model / Serial
    list 3L53-25, lot numbers 03610K000 exp. 10/26/2011;  01711A000 exp. 12/12/2011; 00110L000 exp. 10/29/2011;  01411B000 exp. 01/12/2012; 00611E000 exp. 04/16/2012;
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Algeria, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, India, Indonesia, Ireland, Italy, Japan, Jordan, Latvia, Libya, Lithuania, Luxembourg, Malaysia, Mauritania, Mexico, Netherlands, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Korea, Spain, Switzerland, Taiwan, Trinidad & Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Venezuela.
  • Product Description
    ARCHITECT C-Peptide Reagent Kit; a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of C-Peptide in human serum, plasma and urine on the ARCHITECT i System; Produced by Biokit S.A., 08186 Barcelona, Spain for Abbott Diagnostics Division, Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA and Abbott, 65205 Wiesbaden, Germany; list 3L53-25 || The ARCHITECT C-Peptide assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of C-Peptide in human serum, plasma and urine on the ARCHITECT i System. The ARCHITECT C-Peptide assay is used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Manufacturer Address
    Abbott Laboratories, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA