Events

Recall of Device Recall ARCHITECT Reaction Vessel

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
    51254
  • Event Risk Class
    Class 2
  • Event Number
    Z-1392-2009
  • Event Initiated Date
    2009-02-26
  • Event Date Posted
    2009-05-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79476
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    Abbott has had an increase in complaints due to the receipt of error code 1006 (unable to process test, background read failure), error code 1007 (unable to process test, activated read failure) and incorrect results when using these lots of architect reaction vessels.
  • Action
    Consignees were contacted by phone and sent an "Urgent Field Safety Notice Product Recall" dated February 26, 2009. The letter informed users of the problem and detailed how to identify and discard the affected product. In addition, Abbott Laboratories asked the consignees to send a copy of the letter to any laboratory to which they may have forwarded any of affected lots. Abbott sent a second letter dated May 12, 2009 informing consignees of a recall expansion of additional affected lots. The recall was again expanded on 12/17/09 for an addtional 40 lots of reaction vessels. For additional information, contact Abbott Labs at 1-877-4ABBOTT.

Device

Device Recall ARCHITECT Reaction Vessel
  • Model / Serial
    Product Number: 7C15-01; Lot Numbers: 68446P100, 69061P100, 69283P100, 68487P100, 69063P100, 69284P100, 68488P100, 69082P100, 69340P100, 68489P100, 69176P100, 69341P100, 68491P100, 69177P100, 69342P100, 68492P100, 69178P100, 69353P100, 68511P100, 69179P100, 69433P100, 68513P100, 69180P100, 69434P100, 68515P100, 69205P100, 69435P100, 68516P100, 69206P100, 69436P100, 68553P100, 69207P100, 69438P100, 69006P100, 69208P100, 69439P100, 69007P100, 69209P100, 69521P100, 69008P100, 69266P100, 69522P100, 69009P100, 69267P100, 69523P100, 69010P100, 69280P100, 69526P100, 69058P100, 69281P100, 69527P100, 69060P100, 69282P100 and 69660P100, 68306P100, 68389P100, 68390P100, 68391P100, 68392P100, 68393P100, 69684P100, 73657P100, 73742P100, 74114P100, 74115P100, 74117P100, 74235P100, 74277P100 and 74283P100.  The recall was expanded to include an additional 40 lots on 12/7/09: 62616P100, 62756P100, 65386P100, 65388P100, 65740P100, 68007P100, 68097P100, 68119P100, 68241P100, 69683P100, 69686P100, 70421P100, 70431P100, 70563P100, 70565P100, 70598P100, 70601P100, 71077P100, 71092P100, 71168P100, 71234P100, 71235P100, 71239P100, 71304P100, 71447P100, 71448P100, 71450P100, 71451P100, 71515P100, 71519P100, 71550P100, 71554P100, 71555P100, 71558P100, 72252P100, 72293P100, 73319P100, 73464P100, 78387P100, and 80275P100.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide including Puerto Rico, and internationally to Canada, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Chile, Argentina, Dominican Republic, Honduras, Nicaragua, Germany, Japan, Hong Kong, Taiwan, Thailand, South Korea, Uruguay, Austria, Bahrain, Belarus, Belgium, Bosnia & Herzegovia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, India, Indonesia, Ireland, Italy, Jamaica, Kuwait, Luxembourg, Malaysia, Netherlands, Norway,Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Zimbabwe and Australia.
  • Product Description
    ARCHITECT Reaction Vessel, 2000 units per carton; for in vitro diagnostic use with the ARCHITECT i System; Abbott Laboratories, Abbott Park, IL 60064; list 7C15-01. || The ARCHITECT Reaction Vessels are disposable containers in which the Chemiluminescent Microparticle Immunoassay (CMIA) reaction takes place for sample analysis.
  • 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